DETAILED ACTION
Acknowledgments
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This action is in reply to the RCE amendment and response filed on 11/24/2025.
Claims 1, 14, and15 have been amended.
Claims 1-15 are currently pending and have been examined.
Response to Arguments
Claim Interpretation
After careful review of the original specification, the Examiner is unable to locate any lexicographic definitions with the required clarity, deliberateness, and precision. See MPEP §2111.01 IV.
Terms such as “when”, “if”, “only if”, “on the condition”, “in the event” and “in a case where” are representative of optional limitations; therefore, optional or conditional language do not narrow the claims because they can always be omitted.
Arguments and Assertions by the Applicant
Applicant’s arguments received 08/15/2025 with respect to the prior art rejections have been considered but are moot in view of the new ground(s) of rejection.
With regard to claim 3, the common knowledge declared to be well-known in the art is hereby taken to be admitted prior art because the Applicant either failed to traverse the Examiner’s assertion of OFFICIAL NOTICE or failed to traverse the Examiner’s assertion of OFFICIAL NOTICE adequately. See MPEP §2144.03. To adequately traverse the examiner’s assertion of OFFICIAL NOTICE, the Applicant must specifically point out the supposed errors in the Examiner’s action, which would include stating why the noticed fact is not considered to be common knowledge or well-known in the art. A general allegation that the claims define a patentable invention without any reference to the Examiner’s assertion of OFFICIAL NOTICE would be inadequate. Support for the Applicant’s assertion of should be included.
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 of this title, 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.
Claims 1, 2, and 4-15 are rejected under U.S.C. 103 as being unpatentable over Burton (USPGP 2021/0169417 A1) hereinafter BURTON, in view of Freeman et al. (USPGP 2018/0040255 A1), hereinafter FREEMAN.
Claims 1, 14, 15:
BURTON as shown below discloses the following limitations:
one or more processors configured to: (see at least paragraphs 0226, 0584, 1194)
collect data while worn including at least biological information of a wearer in a healthy state; (see at least paragraphs 0002, 0226-0231, 0812, 0879, 1880)
store approval information for controlling output of the data while worn by prior approval of the wearer; (see at least paragraphs 0560, 0787)
BURTON does not specifically disclose:
request for provision of the data while worn for a medical device that generates medical diagnostic information to collate contents of the data provision request with the data while worn and the approval information;
provide the data while worn to the medical device based on a collation result between the approval information and the contents of the data provision request, wherein the data while worn to be provided is selected from the contents of the data provision request.
FREEMAN, however, in at least paragraph 0236 does. In this case, each of the elements claimed are all shown by the prior art of record but not combined as claimed. Therefore, the technical ability exists to combine the elements as claimed and the results of the combination are predictable. Therefore, when combined, the elements perform the same function as they did separately. (KSR v. Teleflex, 127 S. Ct. 1727 (2007)). Consequently, it would have been obvious to one of ordinary skill in the art at the effective filing date to combine/modify the method of BURTON with the technique of FREEMAN because, “Acute care is delivered to patients in emergency situations in the pre-hospital and hospital settings for patients experiencing a variety of acute medical conditions involving the timely diagnosis and treatment of disease states that, left alone, will likely degenerate into a life-threatening condition and, potentially, death within a period of 72 hours or less. Stroke, dyspnea (difficulty breathing), traumatic arrest, myocardial infarction and cardiac arrest are a few examples of disease states for which acute care is delivered to patients in an emergency setting. Acute care comprises different treatment and/or diagnosis, depending upon the disease state.” (FREEMAN: paragraph 0002). Additionally, there is a recognized problem or need in the art including market pressure, design need, etc., and there are a finite number of identified predictable solutions. Accordingly, those in the art could have pursued known solutions with reasonable expectation of success. (KSR v. Teleflex, 127 S. Ct. 1727 (2007)). Fundamentally, in the competitive business climate, there is a profit-driven motive to maximize the profitability of goods and services that are provided or marketed to customers. Enterprises typically use business planning to make decisions in order to maximize profits.
Claim 2:
The combination of BURTON/FREEMAN discloses the limitations as shown in the rejections above. BURTON further discloses the following limitations:
wherein the one or more processors are configured to:
classify the data while worn for each measurement item;
store the approval information in which whether or not to provide data is set for each measurement item.
See at least paragraphs 0560, 0787, 2395, 3744-3746, and 3815.
Claim 4:
The combination of BURTON/FREEMAN discloses the limitations as shown in the rejections above. BURTON further discloses the following limitations:
wherein the one or more processors are configured to:
acquire medical device information from the medical device;
provide the data while worn to the medical device based on the approval information and the medical device information.
See at least paragraphs 0002, 0226-0231, 0560, 0787, 0812, 0879, and 1880.
Claim 5:
The combination of BURTON/FREEMAN discloses the limitations as shown in the rejections above. BURTON further discloses the following limitations:
wherein the one or more processors are configured to:
acquire affiliation information of the medical device from the medical device information;
provide the data while worn according to the affiliation information.
See at least paragraph 0546.
Claims 6, 7:
The combination of BURTON/FREEMAN discloses the limitations as shown in the rejections above. BURTON further discloses the following limitations:
wherein the one or more processors are configured to:
discriminate the medical device for performing machine learning from the medical device information;
provide the data while worn for generation of the medical diagnostic information using the machine learning.
wherein the one or more processors are configured to:
discriminate the medical device for performing machine learning from the medical device information;
provide the data while worn for a re-training process in the machine learning.
See at least paragraphs 2541, 2545, 2569, 2749-2754.
Claims 8, 9:
The combination of BURTON/FREEMAN discloses the limitations as shown in the rejections above. BURTON further discloses the following limitations:
wherein the one or more processors are configured to:
perform biometric authentication of the wearer;
receive the prior approval in a case where the wearer is determined by the biometric authentication.
wherein the one or more processors are configured to display the approval information on a screen by the biometric authentication.
See at least paragraph 3021.
Claims 10, 11:
The combination of BURTON/FREEMAN discloses the limitations as shown in the rejections above. BURTON further discloses the following limitations:
wherein the one or more processors are configured to create the approval information using proxy approval by a proxy different from the wearer, instead of the prior approval.
wherein the one or more processors are configured to:
register in advance an external input device capable of creating the approval information;
receive the approval information from the external input device; and provide the data while worn.
See at least paragraphs 0560 and 0994.
Claim 12:
The combination of BURTON/FREEMAN discloses the limitations as shown in the rejections above. BURTON further discloses the following limitations:
wherein the one or more processors are configured to:
store the data while worn in an external storage device;
provide the data while worn to the medical device from the external storage device in response to the approval information and the data provision request.
See at least paragraphs 1214 and 3247-3249.
Claim 13:
The combination of BURTON/FREEMAN discloses the limitations as shown in the rejections above. BURTON further discloses the following limitations:
wherein the one or more processors are configured to permit access to the external storage device and display access means on a screen by biometric authentication or a specific operation by a medical worker based on the approval information.
See at least paragraph 1214, 3021, and 3247-3249..
Claims 3 is rejected under 103(a) U.S.C. 103 as being unpatentable over BURTON/FREEMAN and further in view of Applicant’s own admissions, hereinafter AOA.
Claim 3:
The combination of BURTON/FREEMAN discloses the limitations as shown in the rejections above. BURTON/FREEMAN does not specifically disclose:
wherein the one or more processors are configured to:
store the approval information in which an expiration date is set;
give a notification at an end of the expiration date;
receive an update operation of the expiration date.
However, the Examiner accepts AOA that it is old and well known in the electronic data arts to set termination rules for sensitive and personal data. Therefore, it would have been obvious to one of ordinary skill in the art at the effective filing date to combine/modify the method of BURTON/FREEMAN with the technique of expiration dates because there is a recognized problem or need in the art including market pressure, design need, etc., and there are a finite number of identified predictable solutions. Consequently, those in the art could have pursued known solutions with reasonable expectation of success. (KSR v. Teleflex, 127 S. Ct. 1727 (2007)). Additionally, there is a recognized problem or need in the art including market pressure, design need, etc., and there are a finite number of identified predictable solutions. Accordingly, those in the art could have pursued known solutions with reasonable expectation of success. (KSR v. Teleflex, 127 S. Ct. 1727 (2007)). In the competitive business climate, there is a profit-driven motive to maximize the profitability of goods and services that are provided or marketed to customers. Enterprises typically use business planning to make decisions in order to maximize profits.
CONCLUSION
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Non-Patent Literature:
Lin Lu et al. “Wearable Health Devices in Health Care: Narrative Systematic Review.” (2020 Nov 9). Retrieved online 06/09/2025. https://pmc.ncbi.nlm.nih.gov/articles/PMC7683248/
Jayoung Kim et al. “Wearable biosensors for healthcare monitoring.” (2019 Feb 25). Retrieved online 06/09/2025. https://pmc.ncbi.nlm.nih.gov/articles/PMC8183422/
Jan Benedikt Brönneke et al. “Regulatory, Legal, and Market Aspects of Smart Wearables for Cardiac Monitoring.” (20 July 2021). Retrieved online 06/09/2025. https://www.mdpi.com/1424-8220/21/14/4937
Foreign Art:
SEGUIN. “Method For Performing Guided Medical Examination, Involves Determining Medical Diagnosis Based On Visual Data And Sensor Data Using Algorithms Trained To Determine Medical Diagnoses.” (WO 2023/031769 A1)
LEINFELLNER et al. “Wearable Sensor Platform For Monitoring Health Of User, Has A Processor That Determines Differential Readings Between Pairs Of Sensors Of Multiple Sensors Using Adjusted Algorithms And Based On Captured Raw Sensor Data.” (WO 2021/252629 A1)
NAHAPETIAN et al. “Method For Organizing Data Collection And Processing Data From Multiple Sensors By Computing System Utilized In Semantic Medical Application, Involves Analyzing Additional Data To Obtain Refined Diagnosis.” (WO 2011/129817 A2)
Any inquiry of a general nature or relating to the status of this application or concerning this communication or earlier communications from the Examiner should be directed to James A. Reagan (james.reagan@uspto.gov) whose telephone number is 571.272.6710. The Examiner can normally be reached Monday through Friday from 9 AM to 5 PM. If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, John Hayes, can be reached at 571.272.6708.
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/JAMES A REAGAN/Primary Examiner, Art Unit 3697
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