DETAILED ACTION
Status of Claims
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 a response filed 18 February 2026, on an application filed 17 July 2019, which claims domestic priority to a provisional application filed 22 January 2010.
A terminal disclaimer was previously filed by the Applicant over U.S. Patent # 10,453,157 on 24 October 2023. This terminal disclaimer has been approved by the Office.
Claim 30 has been canceled by amendment.
Claims 6-29 are currently pending and have been examined.
EXAMINATION NOTE
The Office notes that the claims contain multiple terms that are not explicitly defined in the claims or the specification as filed. Therefore, the Office is providing the following definitions under a broadest reasonable interpretation analysis.
The online Wiktionary dictionary defines:
web service as a “software system designed to support interoperable machine to machine interaction over a network”;
web server as “software that delivers web pages and other documents to browsers using the HTTP protocol”; and
pair as “To group into one or more sets of two.”
The online Wikipedia describes a gateway as “a link between two computer programs or systems such as Internet Forums. A gateway acts as a portal between two programs allowing them to share information by communicating between protocols on a computer or between dissimilar computers.”
The online Computer Desktop Encyclopedia describes a web client as “[t]he client, or user, side of the Web. It typically refers to the Web browser in the user's machine.”
The online Collins Dictionary describes a transaction as “the transmission and processing of an item of data.”
The Office notes the Applicant’s comments regarding these notes filed 17 April 2023.
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 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 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.
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 6, 10, 11, 15-23, 26, 27 and 30 are rejected under 35 U.S.C. 103(a) as being obvious over De La Huerga et al. (U.S. PG-Pub 2002/0084904 A1), hereinafter De La Huerga, in view of Baldus et al. (U.S. PG-Pub 2009/0184842 A1), hereinafter Baldus, in view of Mensinger et al. (U.S. Patent 8,229,535 B2), hereinafter Mensinger, further in view of Mensinger et al. (U.S. PG-Pub 2009/0192366 A1), hereinafter Mensinger2.
As per claims 6, 10, 11 and 15, De La Huerga discloses a system and method for electronic patient care utilizing a medical device, a wearable dock, and a wearable system monitor configured for monitoring operation of the medical device and to be for electronic patient care, the system (De La Huerga, Figs. 1, 2.) comprising:
identifying a caregiver by the wearable system monitor (Physician identification is provided to the docked transceiver [the wearable system monitor], which provides it to external devices, see paragraphs 165-166.),
record the time when the wearable system monitor is detached from the wearable dock (System logs the time that the transceiver is removed from the bracelet, see paragraphs 125 and 177. System provides indicator alarm when transceiver is not docked, see paragraph 152. System provides security functions when transceiver is detached from bracelet, see paragraphs 175-177, including no longer presenting patient identifying information to external devices, which would inhibit treatment, see paragraphs 126 and 134.);
inhibit a treatment of the medical device when a predetermined amount of time has elapsed without the wearable system monitor being docked into the wearable dock (Medical device will not begin treatment if the transceiver is not currently docked into the correct bracelet for any amount of time, which would be a predetermined amount of time, see paragraphs 126 and 134.),
identify a patient by the wearable system monitor; if the patient is identified, then permit pairing (Wearable system monitor docked into the dock provides patient identifying information, see Fig. 2 #116. See also paragraphs 123 and 126. In another embodiment, bracelet actively identifies the patient through use of a transponder, see paragraph 146.),
... allow the caregiver to pair the wearable system monitor ... (System is paired via identification of patient wearing wearable dock and transceiver, see paragraph 126.),
pair the wearable system monitor with the medical device (System is paired via identification of patient wearing wearable dock and transceiver, see paragraph 126.),
reattaching the wearable system monitor to the wearable dock (Transceiver #200 of Figs. 1-3 is dockable to the wrist strap #100.),
identify and authenticate the wearable dock (Docked transceiver, and therefore wearable dock, is identified and authenticated when placed near HHD 300, see Fig. 9 and paragraphs 123 and 126-127. In another embodiment, bracelet actively identifies the patient through use of a transponder, see paragraph 146.), and
resume the treatment of the medical device after the wearable system monitor is docked into the wearable dock, and the wearable dock is identified and authenticated by the wearable system monitor (Paragraphs 126 and 133.);
wherein the wearable system monitor is configured for monitoring operation of the medical device (Transceiver #200 of Figs. 1-3 is dockable to the wrist strap #100, see also transceiver #420 of Fig. 11); and
11. a medical device configured to treat the patient (Paragraph 126.);
a wearable dock (De La Huerga, patient identifying wrist-strap, See Figs. 1-2 #100 and Figs. 11-13 #400.); and
a wearable system monitor configured for monitoring operation of the medical device and to be dockable to the wearable dock (Transceiver #200 of Figs. 1-3 is dockable to the wrist strap #100, see also transceiver #420 of Fig. 11.).
A secondary embodiment of De La Huerga discloses stopping treatment when the verification of a patient’s identity has been interrupted, see paragraph 210 where the system stops collecting measurements after the patient’s identification is no longer being verified. However, De La Huerga fails to explicitly disclose:
start a timer when identification verification is interrupted, performing operations after the timer has measured a predetermined amount of time;
determine by the wearable system monitor if the caregiver is authorized to pair the wearable system monitor with the medical device, and pair only if the caregiver has been determined to be authorized;
a medical device monitor that is enabled for communicating a condition detected during the treatment, analysis of the condition and a suggestion corresponding to the condition; and
10, 15. wherein the medical device is an infusion pump.
Baldus teaches that it was old and well known in the art of healthcare communications at the time of the invention/filing to start a timer when identification verification is interrupted, performing operations after the timer has measured a predetermined amount of time (See paragraphs 22-27.) and an infusion pump (Baldus, paragraph 20.).
De La Huerga discloses a system that records the time when the wearable system monitor is detach from the wearable dock, as well as a system that stops treatment when the patient’s identity is no longer being verified; note that in the present application detachment of the monitor is associated with verification of patient identity, see Fig. 14 #1018-1026, and paragraph 4, wherein only monitors that are still attached go on to verify the patient identity. De La Huerga fails to explicitly disclose starting a timer. That is, treatment will not continue if the dock is unattached or the patient has not been verified. Baldus discloses starting a timer when the patient’s identity verification is interrupted at paragraphs 22-27. Given all of the elements of De La Huerga and Baldus, it would be obvious to one of ordinary skill in the art to arrive at a system that started a timer when the wearable system monitor is detached from the dock, as to do so would result in a process to verify that a patient is the correct patient without prematurely stopping the treatment process.
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the patient electronic identification apparatus of De La Huerga to include provide starting a timer when it cannot verify an identification code and stopping normal operation of a medical device treatment after a timeout period has elapsed and an infusion pump, as taught by Baldus, because it would arrive at a patient electronic identification apparatus that started a timer when the monitoring device was detached, thereby providing a process to verify that a patient is the correct patient without prematurely stopping the treatment process, which would assist the provision of patient care.
Neither De La Huerga nor Baldus specifically disclose only pairing devices upon a determination that the pairer has authority to pair the devices and a medical device monitor that is enabled for communicating a detected condition, an analysis thereof and a suggestion corresponding to the condition.
Mensinger, however, teaches that it was old and well known in the art of healthcare communications before the effective filing date of the claimed invention to disclose only pairing devices upon a determination that the pairer has authority to pair the devices in order to provide more secure healthcare communications between healthcare devices (Mensinger, C15L39-52.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the patient electronic identification apparatus of De La Huerga/Baldus to include the pairing functionality taught by Mensinger, in order to result in a patient electronic identification apparatus that provides more secure healthcare communications between healthcare devices and provides corresponding alerts as needed (Mensinger, C15L39-52 and C32L45-62.).
Neither De La Huerga nor Baldus nor Mensinger specifically disclose a medical device monitor that is enabled for communicating a medical condition detected during the treatment, analysis of the medical condition and a suggestion corresponding to the medical condition.
Mensinger2, however, teaches that it was old and well known in the art of healthcare communications before the effective filing date of the claimed invention to disclose a medical device monitor that is enabled for communicating a medical condition detected during the treatment, analysis of the medical condition and a suggestion corresponding to the medical condition (Mensinger2 provides a system that communicates a detected medical condition as well as an analysis thereof and a corresponding suggestion, see Mensinger2 Fig. 4D, wherein a detected condition, the detection of the number of analytes in the body #460 is shown along with an analysis of the rate of change thereof #462; see also Fig. 14 and corresponding text. Mensinger2 also discloses providing instructions corresponding to the detected medical condition, see paragraphs 565 and 587. Mensinger2 also detects ischemia at least, see paragraphs 337, 486 and 495.) in order to provide a medical device with self-monitoring functionality in order to increase reliability and safety.
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the patient electronic identification apparatus of De La Huerga/Baldus/Mensinger to include the device monitor that is enabled for communicating a medical condition detected during the treatment, analysis of the medical condition and a suggestion corresponding to the medical condition, as taught by Mensinger2, in order to result in a patient electronic identification apparatus that provides a medical device with self-monitoring functionality in order to increase reliability and safety.
De La Huerga, Baldus, Mensinger and Mensinger2 are all directed to the monitoring and transmission of patient data in order to provide secure medical services to the patient. Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
As per claims 16-23, 26, 27 and 30, De La Huerga/Baldus/Mensinger/Mensinger2 disclose claims 1 and 8, discussed above. De La Huerga/Baldus/Mensinger fail to explicitly disclose but Mensinger2 discloses:
16,19. determining the medical condition based on a plurality of physiological variables (Mensinger2 detects a medical condition such as hypoglycemia from a plurality of physiological variables, such as glucose levels, ph levels and the amount of oxygen in the blood or the regional temperature, which is used to filter the measured glucose level to reduce signal noise, see Fig. 14 and paragraphs 337, 490, 493, 495, 540, 578, 581 and claim 11);
17,20. wherein the physiological variables are selected from: heart activity; body temperature; regional temperature; blood oxygen saturation; pulse; blood pressure; hear rate; blood glucose level; respiration rate; galvanic skin response; skin surface temperature; ventricular pressure; muscular activity; brain activity; body position; heart image; artery diameter; blood chemistry; acid-base balance; functioning lung volume; and combinations thereof (Mensinger2 detects a medical condition such as hypoglycemia from a plurality of physiological variables, such as glucose levels, PH levels and the amount of oxygen in the blood or the regional temperature, which is used to filter the measured glucose level to reduce signal noise, see Fig. 14, paragraphs 337, 490, 493, 495, 540, 578 and 581 and claim 11);
18,21. wherein the medical condition is selected from: a heart attack; a fever; diabetes; hypertension; pulmonary disease; stress; aortic stenosis; seizure; an ulcer; arteriosclerosis; liver disease; muscle damage; ischemia; heart failure; a coronary syndrome; gastroesophageal reflux; asthma; and combinations thereof (Mensinger2 detects ischemia at least, see paragraphs 337, 486 and 495.);
22,26. wherein said identifying a caregiver comprises authenticating the caregiver (Physician identification is provided to the docked transceiver [the wearable system monitor], which provides it to external devices, see paragraphs 165-166.);
23,27. wherein said identifying a patient comprises authenticating the patient (Wearable system monitor docked into the dock provides patient identifying information, see Fig. 2 #116. See also paragraphs 123 and 126. In another embodiment, bracelet actively identifies the patient through use of a transponder, see paragraph 146.); and
30. wherein said identifying and authenticating comprises the wearable dock (Physician identification is provided to the docked transceiver [the wearable system monitor], which provides it to external devices, see paragraphs 165-166.).
in order to provide a medical device with self-monitoring functionality in order to increase reliability and safety.
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the patient electronic identification apparatus of De La Huerga/Baldus/Mensinger to include the device monitor that is enabled for detecting a medical condition based on a plurality of physiological variables such as temperature, PH and glucose, and wherein the medical condition includes ischemia, as taught by Mensinger2, in order to result in a patient electronic identification apparatus that provides a medical device with self-monitoring functionality in order to increase reliability and safety.
Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
Claims 7-9 and 12-14 are rejected under 35 U.S.C. 103(a) as being obvious over De La Huerga/Baldus/Mensinger/Mensinger2, further in view of Blomquist (U.S. patent 8,954,336 B2), hereinafter Blomquist.
As per claims 7-9 and 12-14, De La Huerga/Baldus/Mensinger/Mensinger2 disclose claims 1 and 8, discussed above. De La Huerga/Baldus/Mensinger/Mensinger2 fail to explicitly disclose:
7, 12. a gateway configured to provide at least one of a routing functionality, a medical device software update, and a web service, wherein the medical device is configured to operatively communicate with the gateway using the web service;
8, 13. wherein the gateway is a web server of the web service and the medical device is a client of the web service; and
9, 14. wherein the web service is a transaction-based web service;
However Blomquist teaches that it was old and well known in the art of healthcare communications before the effective filing date of the claimed invention to provide:
7, 12. a gateway configured to provide at least one of a routing functionality, a medical device software update, and a web service, wherein the medical device is configured to operatively communicate with the gateway using the web service (Blomquist, Fig. 1 #100 and Fig. 4 #134. The pump server #100 provides a gateway to communicate with the medical device via a web service, the pump interface driver. See also Col. 3, line 61 to Col. 4, line 10, where the pump server serves a web service (web browser interface) to the medical device and Fig. 7.);
8, 13. wherein the gateway is a web server of the web service and the medical device is a client of the web service (See Blomquist, Col. 3, line 61 to Col. 4, line 10, where the pump server serves a web service (web browser interface) to the medical device and Fig. 7.); and
9, 14. wherein the web service is a transaction-based web service (Blomquist, Col. 3, line 61 to Col. 4, line 10, where the pump server serves a web service (web browser interface) to the medical device and Fig. 7. This is clearly the transmission and processing of an item of data.),
in order to transmit patient data to other networked computing devices for additional detection of patient conditions utilizing additional communication specifications thereby increasing the access to the patient's data and the potential for diagnosis of patient conditions.
Note the definitions of gateway, web service, web client, web server, and transaction indicated above.
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the patient electronic identification apparatus of De La Huerga/Baldus/Mensinger/Mensinger2 with Blomquist’s communication of medical data using a transaction based web service and a gateway, because to do so would result in a patient electronic identification apparatus that could further transmit patient data to other networked computing devices for additional detection of patient conditions utilizing additional communication specifications, thereby increasing the access to the patient's data and the potential for diagnosis of patient conditions.
De La Huerga and Blomquist are both directed to the monitoring and transmission of patient data in order to provide secure medical services to the patient. Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
Claims 24, 25, 28 and 29 are rejected under 35 U.S.C. 103(a) as being obvious over De La Huerga/Baldus/Mensinger/Mensinger2, further in view of Levien et al. (U.S. PG-Pub 2006/0281409 A1), hereinafter Levien.
As per claims 24, 25, 28 and 29, De La Huerga/Baldus/Mensinger/Mensinger2 disclose claims 1 and 8, discussed above. De La Huerga/Baldus/Mensinger/Mensinger2 fail to explicitly disclose:
24,28. wherein said identifying a caregiver comprises biometric reading; and
25,29. wherein said identifying a patient comprises biometric reading.
However Levien teaches that it was old and well known in the art of healthcare communications before the effective filing date of the claimed invention to provide use of biometrics to identify users (Levien, paragraphs 41 and 65.) in order to provide more secure access to systems.
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the patient electronic identification apparatus of De La Huerga/Baldus/Mensinger/Mensinger2 with Levien’s use of biometrics to identify users, because to do so would result in a patient electronic identification apparatus that could provide more secure access to systems.
De La Huerga and Levien are both directed to the monitoring and transmission of patient data in order to provide secure medical services to the patient. Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
Response to Arguments
Applicant’s arguments filed 18 February 2026 concerning the rejection of claim 30 under 35 U.S.C. 112(b) have been fully considered and are persuasive in view of the cancellation of claim 30. Accordingly, this rejection has been removed.
Applicant’s arguments filed 18 February 2026 concerning the rejection of all claims under 35 U.S.C. 103 have been fully considered but they are not persuasive.
The Applicant argues on pages 7-10 that the prior art rejection fails to disclose:
A. The ‘904 Publication does not disclose identifying a caregiver by the wearable system monitor, rather the ‘904 Publication describes transmission of a internet network address without any identification.
B. The ‘842 Publication does not disclose starting a timer.
C. The present claims differ from the ‘904 Publication in that the present claims “waits an amount of time before stopping a treatment whereas the latter stops treatment immediately when there is no match.”
D. The present claims use a wearable system monitor to identify a patient whereas ‘904 describes a physician verifying information queried from an assembly secured about a person’s wrist.
The Office respectfully disagrees.
Regarding A., ‘904 describes use of a wearable monitor to transmit information that identifies the user of the device that transmits the information as belonging to a particular caregiver. See paragraph 165 wherein the physician device transmits information “corresponding to the physician to the transceiver”, which comprises the monitor identifying the physician.
Regarding B., ‘842 at paragraph 24 describes starting a timer when identification verification is interrupted: “If no ID code is being received 88, the medical device 22 waits for reception for the pre-specified period of time T2, e.g. ID timeout 90 such as 15 sec.”
Regarding C., as shown above, the rejection is made over a combination of references, not just ‘904:
De La Huerga discloses a system that records the time when the wearable system monitor is detach from the wearable dock, as well as a system that stops treatment when the patient’s identity is no longer being verified; note that in the present application detachment of the monitor is associated with verification of patient identity, see Fig. 14 #1018-1026, and paragraph 4, wherein only monitors that are still attached go on to verify the patient identity. De La Huerga fails to explicitly disclose starting a timer. That is, treatment will not continue if the dock is unattached or the patient has not been verified. Baldus discloses starting a timer when the patient’s identity verification is interrupted at paragraphs 22-27. Given all of the elements of De La Huerga and Baldus, it would be obvious to one of ordinary skill in the art to arrive at a system that started a timer when the wearable system monitor is detached from the dock, as to do so would result in a process to verify that a patient is the correct patient without prematurely stopping the treatment process.
One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Here the combination of the cited references disclose the contested limitation.
Regarding D., as shown above, the wearable system monitor docked into the dock provides patient identifying information, see ‘904 Fig. 2 #116. See also ‘904 paragraphs 123 and 126. In another embodiment, bracelet actively identifies the patient through use of a transponder, see paragraph 146.
One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Here the combination of the cited references disclose the contested limitation.
In conclusion, all of the limitations which Applicant disputes as missing in the applied references have been fully addressed by the Office as either being fully disclosed or obvious in view of the collective teachings of De La Huerga, Baldus, Mensinger, Blomquist, Mensinger2, Torgerson and Levien, based on the logic and sound scientific reasoning of one ordinarily skilled in the art at the time of the invention, as detailed in the remarks and explanations given in the preceding sections of the present Office Action and in the prior Office Actions (28 November 2025, 8 September 2025, 2 May 2025, 3 March 2025, 30 August 2024, 16 July 2024, 27 February 2024, 29 August 2023, 19 December 2022, 2 August 2022, 20 January 2022 and 3 August 2021), and incorporated herein.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee 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 date of this final action.
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 Mark Holcomb, whose telephone number is 571.270.1382. The Examiner can normally be reached on Monday-Friday (8-5). If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, Kambiz Abdi, can be reached at 571.272.6702.
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/MARK HOLCOMB/
Primary Examiner, Art Unit 3685
4 March 2025