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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 3, 7 and 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites the limitation "the individuals" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 and 14 each recite in part, determine whether a user has opened a mobile application or “viewed … in the mobile application”, however, the claim does not positively recite the thing or element that the mobile application resides. Claims 7 and 14 are therefore rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: the thing or element onto which the mobile application resides. For examination purposes, it will be presumed that claim 7 and claim 14 each positive recites a mobile device comprising a mobile application as recited in claim 2.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Applicant cited Smith et al. US 20200155025 A1 ("Smith") in view of Nephin et al. US 20050222873 A1 ("Nephin").
Regarding claims 1, 10 and 20, Smith discloses a system, computer readable medium with instructions and associated method (“100” - Fig. 1, [0013-0015], [0028]) comprising: a server (“110”) including one or more processors and one or more computer-readable storage mediums storing instructions, which, when executed by the one or more processors, cause the server to perform an operation comprising ([0029], [0032] [0088]): detecting cardiac events based on electrocardiogram (ECG) data, associating the cardiac events with a criticality ([0015-0016], [0032] “… the workflow may classify (or reclassify) the data to identify a type of the health event-e.g., ... classification”, [0033] “… a cardiac event may be evaluated using different processing nodes 114 in the server 110”), transmitting the ECG data associated with a subset of the cardiac events to a remote computing system based, at least in part, on the criticality ([0035] “..the monitoring system 117 may generate a user interface (UI) for a health event which is then displayed to the care provider 101 by the browser application 122”, [0029] “A care provider 101 may use the computing device 120 to access ( e.g., via a browser application 122, a native application on device 120, etc.) a user interface (UI) hosted by the monitoring system 117”), receiving a confirmation from the remote computer regarding at least one of the cardiac events in the subset of the cardiac events ([0035] “… processing nodes 114 that require input from the care providers 101 … the care provider 101 performs an action (e.g., confirms the classification of the event or agrees with an action suggested by the workflow server 110)”, transmitting an electronic notification to a patient care group regarding the confirmation ([0035] “… the remaining operations of the workflow are performed--- e.g., … route the event to a different one of the care providers 101, reclassify the health event (if the care provider 101 indicated the initial classification was incorrect”).
Although Smith requires routing the even to a different one of the care providers ([0035] “Once the care provider 101 performs an action (e.g., confirms the classification of the event or agrees with an action suggested by the workflow server 110), the remaining operations of the workflow are performed--- e.g., … route the event to a different one of the care providers 101”), Smith does not explicitly disclose determining whether an acknowledgement of the electronic notification has been received from the patient care group within a set period of time.
However, Volpe discloses that it was known in the prior art to issue notifications with preconfigured, programmable time delay, such that first the patient is notified, and if the patient does not respond to the notification (e.g., by acknowledging the notification), a designated person other than the patient is notified after expiration of the time delay, this process ensures that the notification is received and acknowledge by the intended recipient. In view of these teachings, at the time of filing the claimed invention, a person of ordinary skill in the art would apply the teachings of Volpe in the system of Smith, to issue the electronic notification of Smith with a preconfigured, programmable time delay, to allow for the re-routing of the notification to another patient group if a response to the notification is not received, to ensure that there is no lapse in providing feedback or medical assistance and/or feedback to the patient during the critical cardiac event.
Claims 2-5, 7 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Volpe as applied to claim 1 or 10 above, and further in view of Yousif et al. US 20200273558 A1 (“Yousif”).
Regarding claims 2 and 11, Smith in view of Volpe discloses the inventions of claims 1 and 10 as discussed above, but does not explicitly disclose that the electronic notification doe does not include personal health information of a patient associated with the cardiac events. However, it is well known to preserve patient privacy during transfer of health data for remote analysis by stripping patient privacy information from the health data as required by regulations in various jurisdictions as exemplified by Yousif e.g. in [0026], [0029]. In view of these, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art to strip patient privacy information from the electronic notification, so as to protect patient privacy and comply with regulations regarding patient privacy in handling health related data.
Regarding claims 3 and 12, Smith in view of Volpe and Yousif discloses the inventions of claims 2 and 11 as discussed above, Smith disclose in [0029] “A care provider 101 may use the computing device 120 to access ( e.g., via a browser application 122, a native application on device 120, etc.) a user interface (UI) hosted by the monitoring system 117”) and care providers each associated with a corresponding computing device ([0035] “… different one of the care providers 101”), Smith does not explicitly disclose that computing device is a mobile device with a mobile application, wherein the personal health information of the patient can be accessed only via the mobile application. However, Yousif teaches in [0051] and illustration Fig. 2, the stripped patient information discussed above can be retrieved via API 206 and that a mobile device with associated mobile application are well-known art recognized electronic computing devices via a secure communication ([0005], [0053]). In view of these, at the time of filing the claimed invention, inasmuch as Yousif disclose mobile devices with associated mobile applications as art recognized computing devices, it would have been obvious to one of ordinary skill in the exercise art to substitute one for the other to arrive to the claimed invention, In re Fout, 675 F.2d 297, 301, 213 USPQ 532, 536 (CCPA 1982), in the instant case, substitute computing device 120 of Smith with a mobile device as taught by Yousif, to perform the same function and for the added advantage of allowing remote assistance.
Regarding claim 4 and 5, Smith in view of Volpe and Yousif discloses the inventions of claims 3 as discussed above. Smith teaches providing a strip of ECG data associated with the at least one cardiac event [0016], as modified by the teachings of Yousif, the mobile application would be programmed to access the strip of the ECG and the mobile devices and the server include application program that enable secure communications.
Regarding claims 7 and 14, Smith in view of Volpe and Yousif discloses the aspect of a mobile application as discussed in claim 2, in view of the modification in view of Volpe as discussed in claim 1 and 10 above, the acknowledgement would at least comprise opening the mobile application or viewing the cardiac event or report, to respond to the notification.
Claims 8 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Volpe as applied to claim 1 or 10 above, and further in view of Teplitzky et al. US 20200176122 A1 (“Teplitzky”).
Regarding claims 8 and 13, Smith in view of Volpe discloses the inventions of claims 1 and 10 as discussed above, but does not explicitly disclose detecting the cardiac events with the criticality includes processing the ECG data with a neural network. However, Teplitzky discloses in ate last [0056] and [0065] that it was known in the prior art to process ECG data using a neural network. In view of these, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art to process the ECG data using a neural network during the process of detecting the cardiac events with criticality, for fast and more accurate diagnosis.
Claims 6, 9 and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Volpe as applied to claim 1 or 10 above, and further in view of Nephin et al. US 20050222873 A1 (“Nephin”).
Smith in view of Volpe discloses the inventions of claims 1 and 10 as discussed above, but does not explicitly disclose the limitations of claims 6, 9 and 15-19.
As to claim 6, as modified in claim 1 above, Smith in view of Volpe does not explicitly disclose transmitting electronic instructions to the remote computer to contact the patient care group by telephone. However the use of a telephone as means of contacting a health care group is known and as disclosed by Naphin ([0160]), it was known to include a group telephone number in contact information of the group to facilitate contacting the health care group. In view of these, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art to transmit electronic instructions to the remote computer to contact the patient care group in the event that an acknowledgement notification is not received, so as to establish contact with the care group to provide the required assistance to the patient.
As to claim 9 and 15-19, Smith in view of Volpe does not explicitly disclose that the care group comprises a team of individuals and any individual in the group can initiate the acknowledgement [claim 9, 15] and the individual associated with the care group by subscribing, by delegation by a physician. However, Nephin teaches that a care group comprise a team of individuals ([0134]) and that a group administrator can manage care providers within a group ([0179]), the group administrator can be any member of the group e.g., a physician. At the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art to establish a care group as disclosed by Naphin and assign a physician as a group administrator to manage the members or individuals in the group by adding or removing individuals within the care group and giving administrative access to provide or send data to other members who are not in the group and to add the members automatically to the group by forwarding of the notification as these are well known techniques for managing patient care.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONIFACE N NGANGA whose telephone number is (571)270-7393. The examiner can normally be reached Mon. - Thurs. 5:30 am - 4:00 pm.
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/BONIFACE N NGANGA/Primary Examiner, Art Unit 3797