DETAILED ACTION
Notices to Applicant
This communication is a non-final rejection. Claims 2-20, as filed 09/22/2025, are currently pending and have been considered below.
Priority is generally acknowledged as shown on the filing receipt with the earliest priority date being 09/12/2013.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 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.
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 Long!, 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-l.jsp
Claims 2-5 and 7-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of US 11,596,363 B2 and 1-11 of US 12,367,973 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The pending claims are related to the issued claims as described in the tables below.
Pending claim(s)
‘363 claim(s)
‘363 notes
2
1
The pending claim is anticipated the ‘973 claim
16
7
Anticipated
3, 17
1, 7
Anticipated
5, 19
1, 7
Anticipated
4, 18
1,7
Anticipated
7
1
Anticipated
8
1
Anticipated
11
1
Anticipated
12
6
Anticipated
13
2
Anticipated
14
8
Anticipated
15
9
Anticipated
9, 20
1, 7
The issued claims do not disclose syncing data across multiple devices, but the Examiner takes official notice that syncing user profile data across multiple devices associated with that user was well-known before the effective filing date. A POSITA would have been motivated to make claims 9 and 20 because syncing across devices gives users the flexibility to seamlessly use multiple devices.
10
1
Anticipated
Pending claim(s)
‘973 claim(s)
‘973 notes
2
1
Anticipated
16
1
Obvious. The issued claim lacks a system claim, but implementing the method with generic equipment as claimed would have been obvious. See the obviousness rejections below.
3, 5, 17, 19
1, 2, 4, 5
Anticipated
4, 18
1,9
Anticipated
7
1
Anticipated
8
8
Anticipated
10
4, 5
Anticipated
11
1
Anticipated
12
6
Anticipated
9, 20
1
The issued claims do not disclose syncing data across multiple devices, but the Examiner takes official notice that syncing user profile data across multiple devices associated with that user was well-known before the effective filing date. A POSITA would have been motivated to make claims 9 and 20 because syncing across devices gives users the flexibility to seamlessly use multiple devices.
13-15
1
Obvious in view of the prior art presented below. A POSITA would have been motivated to combine the issued claims and the below prior art to arrive at the claim 13 because this would allow health data to be shared with family members in privacy compliant ways, at claim 14 because these different types of measurements would provide greater flexibility in glucose management, and at claim 15 because this would improve the auditability of the device calibration and monitoring.
Claim Objections
Claims 2 and 16 are objected to because of the following informalities. The claims both recite “a calibration mode” twice. The second occurrence in each claim is interpreted as “the calibration mode”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 6 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim, introduced by preliminary amendment on 09/22/2025, contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, the claim requires “wherein the portable medical device transitions to a standby mode if calibration is not completed within a predetermined time period,” but the only disclosure of standby mode is as follows: “The handheld glucometer 200 can operate in a standby mode for a minimum of 18 hours per full charge.” Specification [0050]. The Examiner identifies no support for this limitation; thus it constitutes new matter. Applicant may overcome this rejection by pointing to specific support or by amending the claim.
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 2-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter 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.
Step 1
The claim(s) recite(s) subject matter within a statutory category as a process, machine, and/or article of manufacture which recite:
2. A method for processing physiological measurements, the method comprising:
receiving, by a medical device management system, physiological measurement data from a portable medical device, wherein the physiological measurement data comprises identification information associated with a user of the portable medical device; (insignificant extra-solution activity – mere data gathering)
identifying, by the medical device management system, a user account of the medical device management system based on the identification information; (abstract idea – certain methods of organizing human activity: managing personal interactions/recordkeeping; a person can look up which account a set of readings below to)
initiating, by the medical device management system, a calibration mode on the portable medical device; (abstract idea – following rules or instructions for managing an activity; to the extent that this is non-abstract, it amounts to merely applying the abstract idea with a computer)
transitioning, by the medical device management system, the portable medical device from a measurement mode to a calibration mode in response to initiation of the calibration mode; (abstract idea – following rules or instructions for managing an activity; to the extent that this is non-abstract, it amounts to merely applying the abstract idea with a computer)
restricting, by the medical device management system, the portable medical device from performing at least one physiological measurement while in calibration mode; (abstract idea – following rules or instructions for managing an activity; to the extent that this is non-abstract, it amounts to merely applying the abstract idea with a computer)
transitioning, by the medical device management system, the portable medical device from the calibration mode to the measurement mode upon completion of calibration; (abstract idea – following rules or instructions for managing an activity; to the extent that this is non-abstract, it amounts to merely applying the abstract idea with a computer)
processing, by the medical device management system, the physiological measurement data to determine at least one physiological parameter associated with the physiological measurement data; (abstract idea – mental evaluation or judgment)
transmitting the determined at least one physiological parameter to the portable medical device for display; and (insignificant extra-solution activity – mere data output)
storing, by the medical device management system, the physiological measurement data and the determined at least one physiological parameter in association with the identified user account. (generally applying the abstract idea with a computer)
3. The method of claim 2, further comprising:
accessing, by the medical device management system, a user-specific calibration profile associated with the user account, wherein the user-specific calibration profile is generated from historical invasive and non-invasive physiological measurement data associated with the user account and is stored in a data store of the medical device management system remote from the portable medical device. (abstract idea – certain methods of organizing human activity: managing personal interactions/recordkeeping; a person can look up profile data for a user.)
4. The method of claim 3, further comprising:
updating, by the medical device management system, the user-specific calibration profile in the data store based on subsequent measurement data received from the portable medical device. (abstract idea – certain methods of organizing human activity: managing personal interactions/recordkeeping; a person can update profile data for a user.)
5. The method of claim 3, wherein processing the physiological measurement data to determine at least one physiological parameter comprises using the user-specific calibration profile. (abstract idea – certain methods of organizing human activity: managing personal interactions/recordkeeping; a person can determine a measurement using user-specific profile information.)
6. The method of claim 2, wherein the portable medical device transitions to a standby mode if calibration is not completed within a predetermined time period. (abstract idea – following rules or instructions for managing an activity; to the extent that this is non-abstract, it amounts to merely applying the abstract idea with a computer)
7. The method of claim 2, wherein restricting the portable medical device from performing at least one physiological measurement comprises disabling non-invasive measurements while permitting invasive measurements during calibration mode. (abstract idea – following rules or instructions for managing an activity; to the extent that this is non-abstract, it amounts to merely applying the abstract idea with a computer)
8. The method of claim 2, wherein the portable medical device displays a calibration status indicator while in calibration mode. (insignificant extra-solution activity – mere data output)
9. The method of claim 3, wherein the user-specific calibration profile is synchronized across a plurality of portable medical devices associated with the user account. (abstract idea – following rules or instructions for managing an activity; to the extent that this is non-abstract, it amounts to merely applying the abstract idea with a computer)
10. The method of claim 2, wherein the physiological measurement data comprises at least one of invasive blood glucose measurement data and non-invasive blood glucose measurement data. (insignificant extra-solution activity – mere data gathering)
11. The method of claim 2, wherein the medical device management system communicates with the portable medical device over a wireless communication network. (insignificant extra-solution activity – receiving or transmitting data over a network)
12. The method of claim 2, wherein the physiological measurement data is contained in a structured data file. (insignificant extra-solution activity – mere data gathering; merely applying the abstract idea with a computer)
13. The method of claim 2, further comprising:
providing, by the medical device management system, the determined at least one physiological parameter to a user account different from the identified user account based on one or more privacy settings of the identified user account. (abstract idea – following rules or instructions for managing an activity; to the extent that this is non-abstract, it amounts to merely applying the abstract idea with a computer)
14. The method of claim 2, wherein the medical device management system is configured to process physiological measurement data associated with at least one additional physiological parameter selected from the group consisting of: Oxygen Saturation (SpO2), Total Hemoglobin (SpHb), Alkaline Phosphatase (SpALP), Total Cholesterol (SpChol), High-Density Lipoprotein (SpHDL), and Total Cholesterol Divided by High Density Lipoprotein (SpChol/SpHDL). (abstract idea – following rules or instructions for managing an activity; to the extent that this is non-abstract, it amounts to merely applying the abstract idea with a computer)
15. The method of claim 2, further comprising:
logging, by the medical device management system, calibration events and measurement results in association with the user account. (abstract idea – following rules or instructions for managing an activity; to the extent that this is non-abstract, it amounts to merely applying the abstract idea with a computer)
Claims 2-15 are presented as an exemplary claim but the same analysis applies to the other claims 16-20.
Step 2A Prong One
The broadest reasonable interpretation of these steps includes certain methods of organizing human activity and mental processes because the italicized portions can be performed by a person following rules and exercising judgment. For example, a person managing a home-testing program can determine from a patient identifier whose records are implicated, decide that a device should be set aside for calibration and not used for a reading until calibration is done, and compute a result from a reading using a stored calibration.
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims as shown above.
Step 2A Prong Two
This judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements:
amount to mere instructions to apply an exception. For example, “medical device management system” and “a portable medical device” amount to invoking computers as a tool to perform the abstract idea, see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea. For example, receiving the measurement data and transmitting the parameter for display amounts to mere data gathering and output, see MPEP 2106.05(g))
generally link the abstract idea to a particular technological environment or field of use such as the blood-glucose measurement environment, see MPEP 2106.05(h))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims as described above. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, other than the abstract idea per se amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields such as receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i), performing repetitive calculations, Flook, MPEP 2106.05(d)(II)(ii), electronic recordkeeping, Alice Corp., MPEP 2106.05(d)(II)(iii), and/or storing and retrieving information in memory, Versata Dev. Group, MPEP 2106.05(d)(II)(iv).
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
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.
Claims 2, 8, 10, 11, 16 are rejected under 35 U.S.C. 103 as being unpatentable over Berman (US20070027382A1) in view of Samuels (US20030109773A1).
Regarding claim 2, Berman discloses: A method for processing physiological measurements, the method comprising:
--receiving, by a medical device management system, physiological measurement data from a portable medical device, wherein the physiological measurement data comprises identification information associated with a user of the portable medical device (“All the analyte measurements, behavior attributes, and physiological attributes are communicated to the data processing and storage unit 510 for processing and storage,” [0026]);
--identifying, by the medical device management system, a user account of the medical device management system based on the identification information (“, an account manager 512 in the processing unit 510 accesses the user's account and the security module 511 verifies the user's identity via a password or any other security means,” [0027]);
--initiating, by the medical device management system, a calibration mode on the portable medical device (“If selected, the user selects the desired analyte to be measured 4400 and if calibration is needed, the calibrator module is initiated to calibrate 4500 the processor 214,” [0030]);
--transitioning, by the medical device management system, the portable medical device from a measurement mode to a calibration mode in response to initiation of the calibration mode (“If calibration is complete, the user can obtain measurements from the skin patch 4600 and the analyte measurement generator records 4700 and calculates the analyte level,” [0032]);
--transitioning, by the medical device management system, the portable medical device from the calibration mode to the measurement mode upon completion of calibration (“If calibration is complete, the user can obtain measurements from the skin patch 4600 and the analyte measurement generator records 4700 and calculates the analyte level,” [0032]);
--processing, by the medical device management system, the physiological measurement data to determine at least one physiological parameter associated with the physiological measurement data (“The device 211 may also include a processor 214 for analyzing the measured data and processing the information for display to the user via a graphical display 215,” [0023]; “the analyte measurement generator records 4700 and calculates the analyte level,” [0032]);
--transmitting the determined at least one physiological parameter to the portable medical device for display (“the display 215 will display the measurement,” [0032]); and
--storing, by the medical device management system, the physiological measurement data and the determined at least one physiological parameter in association with the identified user account (“updates the profile database in the account manager 5700,” [0033]).
Berman does not expressly disclose but Samuels teaches:
--restricting, by the medical device management system, the portable medical device from performing at least one physiological measurement while in calibration mode (“Calibration is then performed to ready the device for taking measurement. The system software then increments the counter each time a measurement is made, up to a predetermined maximum. Once the maximum number of measurements is reached, the system software indicates that a calibration is again required, and the device is prevented from taking additional measurements,” [0108]).
One of ordinary skill in the art before the effective filing date would have been motivated to expand the patient monitoring system of Berman to include the calibration-gated measurements of Samuels because this would prevent an unreliable readings from being taken by a poorly-calibrated device. See Samuels [0012].
Regarding claim 8, Berman discloses: wherein the portable medical device displays a calibration status indicator while in calibration mode (“If the marker is detected, then the analyte calibration may be initiated,” [0031]).
Regarding claim 10, Berman discloses: wherein the physiological measurement data comprises at least one of invasive blood glucose measurement data and non-invasive blood glucose measurement data (“measure glucose from skin patches 212 which collect and retain the glucose brought to the skin surface,” [0019]).
Regarding claim 11, Berman discloses: wherein the medical device management system communicates with the portable medical device over a wireless communication network (“All elements of the system can be linked to communicate with each other via a network or wireless protocol 50,” [0017]).
Claims 3-5, 7, 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Berman in view of Samuels and Rebec (US20130303869A1).
Regarding claims 3 and 17, Berman discloses user-specific calibration derived from account information but does not expressly disclose that the user-specific calibration profile is generated form historical invasive and non-invasive physiological measurement data. Rebec teaches: accessing, by the medical device management system, a user-specific calibration profile associated with the user account, wherein the user-specific calibration profile is generated from historical invasive and non-invasive physiological measurement data associated with the user account and is stored in a data store of the medical device management system remote from the portable medical device (“the reader device may be provided with one or more calibration algorithms to calculate one or more correction factors based on a blood-based reference measurement, analyte sensor configuration (e.g., diffusion characteristics of analyte sensor in interstitial fluid), optical correction parameters (e.g. skin characteristics at implantation site, analyte sensor implantation depth), relationship of target analyte concentration in blood to target analyte concentration in interstitial fluid (e.g., a predetermined blood-interstitial fluid conversion factor), previous analyte sensor readings/data trends, and/or other parameters,” [0124]; “the reference measurement may be a blood glucose concentration obtained with a standard glucose test strip, a commercially available blood glucose meter, or other commercially available blood test/meter,” [0126]).
One of ordinary skill in the art before the effective filing date would have been motivated to expand the patient monitoring system of Berman and Samuels to include the calibration profile of Rebec because this would improve the accuracy of subsequent non-invasive measurements by tailoring the calibration to the individual patient (Rebec [0124]-[0126]).
Additionally, it can be seen that each element is taught by either Berman, Samuels, or Rebec. The calibration of Rebec does not affect the normal functioning of the elements of the claim which are taught by Samuels and Berman. Because the elements do not affect the normal functioning of each other, the results of their combination would have been predictable. Therefore, before the effective filing date of the claimed invention, it would have been obvious to combine the teachings of Berman and Samuels with the teachings of Rebec since the result is merely a combination of old elements, and, since the elements do not affect the normal functioning of each other, the results of the combination would have been predictable.
Regarding claim 4, Berman discloses: updating, by the medical device management system, the user-specific calibration profile in the data store based on subsequent measurement data received from the portable medical device (“If the transmission pertains to an existing profile, the data is transferred and the profile database in the account manager is updated 5700. If the transmission consists of data pertaining to a new profile, a new profile is created by the processing unit 5400 and data is transferred 5500. The processing unit then organizes and correlates the data according to the behavioral and physiological relationships and recipient parameters 5600 and updates the profile database in the account manager 5700,” [0033).
Regarding claims 5 and 19, Berman discloses: wherein processing the physiological measurement data to determine at least one physiological parameter comprises using the user-specific calibration profile (“The device 211 may also include a computer-executable code containing a calibration module 217, which relates measured values of the detected glucose to blood glucose values,” [0023]; “After verification, the attributes are transmitted and organized into a physiological database 513, which stores the user's analyte measurements and other physiological attributes, and a behavioral database, which stores the user's behavioral attributes. The account manager 512 also communicates with an information recipient database 515 that includes the user's selected information recipients 600 and recipient parameters associated with each specific information recipient,” [0027]).
Regarding claim 7, Berman does not expressly disclose but Rebec teaches: wherein restricting the portable medical device from performing at least one physiological measurement comprises disabling non-invasive measurements while permitting invasive measurements during calibration mode (“the reference measurement may be a blood glucose concentration obtained with a standard glucose test strip, a commercially available blood glucose meter, or other commercially available blood test/meter,” [0126], “previous analyte sensor readings/data trends,” [0124]. This teaching is viewed in light of Samuels’ restriction of measurement during calibration mode.).
One of ordinary skill in the art before the effective filing date would have been motivated to expand the patient monitoring system of Berman and Samuels that restricts measurements during calibration mode to include the calibration of a non-invasive device with invasive data as taught by Rebec because this would improve the accuracy of subsequent non-invasive measurements by restricting the user to invasive measurements while the system is out of calibration.
Claims 16 and 18 are substantially similar to claims 2 and 4 and are rejected with the same reasoning.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Berman in view of Samuels and Karlsson (US20100235664A1).
Regarding claim 6, Berman does not expressly disclose but Karlsson teaches: wherein the portable medical device transitions to a standby mode if calibration is not completed within a predetermined time period (“when a user stops providing input to a device for more than a particular period of time, the device may enter a power savings mode, in which the device cuts off power from being delivered to certain components,” [0002]).
One of ordinary skill in the art before the effective filing date would have been motivated to expand the patient monitoring system of Berman and Samuels to include the standby mode of Karlsson because this would allow the system to save power as described in Karlsson [0002].
Claims 9 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Berman in view of Samuels, Rebec, and Dicks (US20080183502A1).
Regarding claims 9 and 20, Berman does not expressly disclose but Dicks teaches: wherein the user-specific calibration profile is synchronized across a plurality of portable medical devices associated with the user account (“This would allow a single intermediary device (such as a router, hub, mobile computing device, medical data interchange device, medical data translator, or other device) to allow data from multiple medical devices to be provided to a medical data server or other system implementing methods of the present invention, as well as amongst the different medical devices, even where the medical devices do not share a common communications format or protocol,” [0060]; “Readings from both sets of meters and hubs (cell phones) get merged together in the database based on the child's patient ID,” [0038]).
One of ordinary skill in the art before the effective filing date would have been motivated to expand the patient monitoring system of Berman, Samuels, and Rebec to include the cross-device synchronization of Dicks because allowing a user to monitor his health with multiple synchronized devices would be more convenient for the user (Dicks [0009]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Berman in view of Samuels and Nekkar (US20120226786A1).
Regarding claim 12, Berman does not expressly disclose but Nekkar teaches: wherein the physiological measurement data is contained in a structured data file (“an extensible markup language (XML) format may be used as the file format for the parameter configuration file 104,” [0104]).
One of ordinary skill in the art before the effective filing date would have been motivated to expand the patient monitoring system of Berman and Samuels to include the structured data file of Nekkar because this would allow patients to more easily move their data between platforms.
Additionally, it can be seen that each element is taught by either Berman, Samuels, or Nekkar. The XML file input of Nekkar does not affect the normal functioning of the elements of the claim which are taught by Samuels and Berman. Because the elements do not affect the normal functioning of each other, the results of their combination would have been predictable. Therefore, before the effective filing date of the claimed invention, it would have been obvious to combine the teachings of Berman and Samuels with the teachings of Nekkar since the result is merely a combination of old elements, and, since the elements do not affect the normal functioning of each other, the results of the combination would have been predictable.
Claims 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Berman in view of Samuels and Dicks.
Regarding claim 13, Berman does not expressly disclose but Dicks teaches: providing, by the medical device management system, the determined at least one physiological parameter to a user account different from the identified user account based on one or more privacy settings of the identified user account (“The formatted report and other information can be provided selectively to one or more recipients based on the patient information, patient condition, a relation between the recipient(s) and the patient, and/or whether the one or more recipients are authorized to receive the report… The selective providing of data to users can be automated and performed according to rules (such as from the rules database 228)” [0062]).
One of ordinary skill in the art before the effective filing date would have been motivated to expand the patient monitoring system of Berman and Samuels to include the authorized sharing of Dicks because this would improve healthcare provisioning to the user by allowing the other parties who need the data to access it in a controlled manner (Dicks [0062]).
Additionally, it can be seen that each element is taught by either Berman, Samuels, or Dicks. The controlled sharing of Dicks does not affect the normal functioning of the elements of the claim which are taught by Samuels and Berman. Because the elements do not affect the normal functioning of each other, the results of their combination would have been predictable. Therefore, before the effective filing date of the claimed invention, it would have been obvious to combine the teachings of Berman and Samuels with the teachings of Dicks since the result is merely a combination of old elements, and, since the elements do not affect the normal functioning of each other, the results of the combination would have been predictable.
Regarding claim 15, Berman does not expressly disclose but Dicks teaches: logging, by the medical device management system, calibration events and measurement results in association with the user account (“For example, the patient information, patient condition and formatted report may all be stored as part of a medical record for the patient,” [0075]; “an audit record may be created that includes data fields indicative of the compliance or non-compliance with such regulatory standards. The audit record can be produced and reviewed by auditors to verify that systems and methods for remote patient monitoring are acting in accordance with such regulations,” [0077]).
One of ordinary skill in the art before the effective filing date would have been motivated to expand the patient monitoring system of Berman and Samuels to include the logging of Dicks in order to maintain a verifiable record of device operation of regulatory compliance (Dicks [0077]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Berman in view of Samuels and Al-Ali (US20060226992A1).
Regarding claim 14, Berman does not expressly disclose but Al-Ali teaches: wherein the medical device management system is configured to process physiological measurement data associated with at least one additional physiological parameter selected from the group consisting of: Oxygen Saturation (SpO2), Total Hemoglobin (SpHb), Alkaline Phosphatase (SpALP), Total Cholesterol (SpChol), High-Density Lipoprotein (SpHDL), and Total Cholesterol Divided by High Density Lipoprotein (SpChol/SpHDL) (“Based on this response, a processor determines measurements for SpO2, pulse rate, and can output representative plethysmographic waveforms,” [0007]).
One of ordinary skill in the art before the effective filing date would have been motivated to expand the patient monitoring system of Berman and Samuels to include the SpO2 of Al-Ali because this would provide caregivers with additional useful clinical data that can be used to better monitor the patient’s care.
Conclusion
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/JOSHUA B BLANCHETTE/Primary Examiner, Art Unit 3624
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