DETAILED ACTION
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The following is a Final Office Action in response to claims filed December 30, 2025.
Claims 22-24, 26, 30-42, 44, 46, and 72 are currently pending and have been examined.
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 22-26, 30-42, 44, and 46 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Is the claim to a process, machine, manufacture or composition of matter? (MPEP 2106.03)
In the present application, claims 22-24, 26, 30-42, 44, 46, and 72 are directed to a system (i.e., a machine). Thus, the eligibility analysis proceeds to Step 2A. prong one.
Step 2A. prong one: Does the claim recite an abstract idea, law of nature, or natural phenomenon? (MPEP 2106.04)
The abstract idea recited in claim 22 is:
receive first clinical information, and conduct, during the medical event, one or more of:
(a) displaying at least some of the first clinical information,
(b) displaying information derived from at least some of the first clinical information,
(c) modifying operation of the second medical device based on the first clinical information, and
(d) storing the first clinical information.
The claimed invention is directed to an abstract idea of assessing client/patient risk.
Under the broadest reasonable interpretation, without the recitation of additional elements, the limitations above suggest a process similar to collecting, analyzing, and displaying. Because the limitations above closely follow the steps of collecting information and analyzing the collected information, and the steps involved human judgements, observations, and evaluations that can be practically or reasonably performed in the human mind, the claims recite an abstract idea consistent with the “mental processes” grouping of the abstract ideas, set forth in MPEP 2106.04(a)(2)(III).
Additionally and alternatively, the same claim limitations above recite steps of interactions between people in following rules or instruction in the longstanding medical practice of a clinical data handoff. Under the broadest reasonable interpretation, other than the additional elements of computer components, the limitations recite a process of collecting clinical information of patient and then presenting, analyzing, storing, or acting upon that information. Because the limitations above closely follow the steps standard in healthcare practice performed by healthcare professionals, the claims recite an abstract idea consistent with the “certain methods of organizing human activity” grouping of the abstract ideas, set forth in MPEP 2106.04(a)(2)(II).
Accordingly, the above-mentioned limitations are considered as a single abstract idea, therefore, the claim recites an abstract idea and the analysis proceeds to Step 2A. prong two.
Step 2A. prong two: Does the claim recite additional elements that integrate the judicial exception into a practical application? (MPEP 2106.04)
This judicial exception is not integrated into a practical application because the additional elements merely add instructions to apply the abstract idea to a computer.
The additional elements considered include:
Claim 22: “system for clinical data handoff, the system comprising: a server device communicatively coupled to a network, the server device comprising a memory and at least one a processor communicably coupled to the memory, the memory including instructions that, when executed by the at least one processor, cause the at least one processor to initiate at least one component, the at least one component comprising: a communication component configured to (i) facilitate network communication between the server device and a first medical device during a medical event, (ii) facilitate network communication between the server device and a second medical device during the medical event,” “from the first medical device,” “on the second medical device”, “a remote database;” “a graphical user interface (GUI) configured to facilitate interaction between a user and the communication component.”
In particular, the claim only recites the above-mentioned additional elements to communicate, receive, display, and store information. The computer in the steps is recited at a high-level of generality (i.e., as generic computer components performing a generic computer function; See Applicant’s Specification at least at paragraphs [0108]-[0121]) such that it amounts to no more than mere instructions to apply the exception using a generic computer component. That is, the function of limitations [A]-[E] are steps of adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea as discussed in MPEP 2106.05(f).
While examiner contends that “first medical device” and “second medical device” are part of the abstract idea, they are still nothing more than an attempt to link the additional elements to a field of use. Claim limitations that generally link the use of the judicial exception to a particular technological environment or field of use, even when limiting the use of the idea to one particular environment, do not integrate a judicial exception into a practical application. (See MPEP 2106.05(h)).
Accordingly, these additional claim elements, alone and in combination, do not integrate the abstract idea into a practical application, because (1) they do not effect improvements to the functioning of a computer, or to any other technology or technical field (see MPEP 2106.05(a)); (2) they do not apply or use the abstract idea to effect a particular treatment or prophylaxis for a disease or a medical condition (see the Vanda memo); (3) they do not apply the abstract idea with, or by use of, a particular machine (see MPEP 2106.05(b)); (4) they do not effect a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.05(c)); (5) they do not apply or use the abstract idea in some other meaningful way beyond generally linking the use of the identified abstract idea to a particular technological environment, such that the claim as a whole is more than a drafting effort designated to monopolize the exception (see MPEP 2106.05(e) and the Vanda memo). Therefore, per Step 2A, Prong Two, the claims are directed to an abstract idea not integrated into a practical application.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? (MPEP 2106.05)
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the bold portions of the limitations recited above, were all considered to be an abstract idea in Step2A-Prong Two. The additional elements and analysis of Step2A-Prong two is carried over. For the same reason, these elements are not sufficient to provide an inventive concept. Applicant has merely recited elements that instruct the user to apply the abstract idea to a computer or other machinery. When considered individually and in combination the conclusion, as discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a computer to perform the above-mentioned limitations [A]-[E] amount to no more than mere instructions to apply the function of the limitations to the exception using generic computer component, as discussed in MPEP 2106.05(f), in addition to “first medical device” and “second medical device” for communication and modifying operation are simply being attempts to link the additional elements to a field of use (MPEP 2106.05(h)). The claim as a whole merely describes how to generally “apply” the concept for medical handoff. When the independent claims are considered as a whole, as a combination, the claim elements noted above do not amount to any more than they amount to individually. The operations appear to merely apply the abstract concept to a technical environment in a very general sense. The most significant elements of the claims, that is the elements that really outline the inventive elements of the claims, are set forth in the elements identified as an abstract idea. Therefore, it is concluded that the elements of the independent claims are directed to one or more abstract ideas and do not amount to significantly more. (MPEP 2106.05)
As for dependent claims 23, 24, 26, 30-42, 44, 46, and 72 these claims recite limitations that further define the abstract idea noted in claim 22. The claims further recite additional abstract steps and abstract description of displaying and communicating information, which do not change the abstract idea of the independent claim. The claims recite the additional element of computer components or other machinery at a high level of generality such that it amounts no more than mere instructions to apply the exception, as discussed in MPEP 2106.05(f). Even in combination, these additional elements do not integrate the abstract idea into a practical application and do not amount to significantly more than the abstract idea itself. The claims are ineligible.
In summary, the dependent claims considered both individually and as ordered combination do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. The claims do not recite an improvement to another technology or technical field, an improvement to the functioning of the computer itself, or provide meaningful limitations beyond generally linking an abstract idea to a particular technological environment. Therefore, claims 22-24, 26, 30-42, 44, 46, and 72 are rejected under 35 U.S.C. 101.
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, 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 pre-AIA 35 U.S.C. 103(a) 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 22-24, 31-42, 44, and 72 are rejected under 35 U.S.C. 103 as being unpatentable over Geheb (US 2014/0005736 A1), hereinafter “Geheb,” in view of Packer et al. (US 2014/0365175 A1), hereinafter “Packer.”
Claim 22, Geheb discloses a system for clinical data handoff (Abstract: systems and methods for providing life support protocols on a subject from a first life support device to second life support device; Para. [0022]-[0023]), the system comprising:
a device communicatively coupled to a network (para. [0032], devices are communicatively coupled via a communication path 140, which comprises a wireless LAN (WLAN)), the device comprising a memory and at least one a processor communicably coupled to the memory, the memory including instructions that, when executed by the at least one processor, cause the at least one processor to initiate at least one component (Para. [0032] second life support device 135 acts as a server to the first device 105 by receiving data and serving operating instructions, which includes a controller (i.e., processor) to process information. In para. [0029], “the second life support device 135 generally includes at least one control unit, memory unit”. Para. [0044] and [0048] providing and executing instructions stored in memory), the at least one component comprising:
a communication component configured to (i) facilitate network communication between a first medical device during a medical event and (ii) a second medical device during the medical event (Para. [0013]-[0014], [0031]-[0032], [0041], and [0047]-[0048]) disclosing the communication coupling between the first life support device and second life support device), (iii) receive first clinical information from the first medical device (Para. [0023]-[0024], [0027], [0030]-[0031] the first life support system monitors the medical status of the subject and apply treatment to subject, and storing the monitored/collected information of the subject and communicates to the second life support device 135), and (iv) conduct, on the second medical device during the medical event, one or more of:
(a) displaying at least some of the first clinical information on the second medical device (Para. [0008] and [0010], “the operating instructions from the second life support device include an instruction to apply treatment to the subject from the second life support device. The second life support device can also display the operating instructions. In an embodiment, a monitor can display the operating instructions. In some embodiments, the control unit of the first life support device can provide life support protocol information that indicates at least one of a state of the first life support device and a treatment recommendation. The control unit can receive a prompt from the second life support device to provide the life support protocol information. In some embodiments, the second life support device can control the first life support device to apply treatment from the first life support device to the subject based on the operating instructions.” Para. [0024], “first life support device 105 can include a pacing unit or a monitoring device that records health related information from a subject, such as information about the subject's respiration rate or heart activity. In an embodiment, the first life support device 105 includes an electrocardiograph that can display a subject's electrocardiogram (ECG). The first life support device 105 can be carried by paramedics, emergency health care providers, or first responders, such as police or firemen, or may be the type of life support device that is provided by a business or common carrier (e.g., an airline or bus) for use in an emergency situation. These or other users couple the first life support device 105 with a subject to monitor the subject to diagnose a condition (e.g., cardiac arrest, arrhythmia), or to apply treatment to the subject (e.g., defibrillation therapy, pacing therapy).” Para. [0026], “first life support device 105 can include at least one monitor 120. In an embodiment, the monitor 120 is coupled to the control unit 110 and the memory unit 115 and can display information about the subject such as the subject's ECG, heart rate, or respiration rate. The monitor 120 can also display other information about the subject (e.g., age, weight, etc.) as well as indicate what treatment has been applied to the subject and when that treatment was applied. In an embodiment, the monitor 120 indicates treatment is being applied to the subject during the application of that treatment by the first life support device 105.” In sum, the first life support device has a monitor 120 and the first life support device collects and monitors the subject (patient)’s condition and provide first clinical information such as name, age, weight, respiration rate, heart activity, electrocardiogram, and treatment. Further more detail provided in Para. [0022] teaching the “first life support device can also record and communicate information concerning the monitoring or treatment to a second life support device. Based on this information, the first life support device receives operating instructions from the second life support device, and implements the received instructions, enhancing and providing a seamless integration or escalation of more advanced diagnosis, monitoring or treatment of the subject.” Para. [0029], “the second life support device 135 generally includes at least one control unit, memory unit, monitor and electrode to monitor, diagnose, and apply treatment to a subject.” Para. [0031] teaching the second life support device, later arrives on scene, is more advanced than the first life support device and can monitor or apply treatment to the subject that is beyond the capabilities of the first life support device. Continue in para. [0032], “the control unit 110 of the first life support device 105 communicates information about the subject to the second life support device 135, and receives instructions from the second life support device 135 via at least one wired or wireless communication path 140. For example, communications path 140 may comprise any type interface or network such as a Universal Serial Bus (USB), local area network (LAN), Wireless LAN (WLAN), Patient Area Network (PAN) and/or Medical Body Area Network (MBAN). The first life support device 105 can implement these instructions while operatively coupled with the subject, and in an embodiment can operate under the control of the second life support device 135 that is in communication with first life support device 105 via communication path 140, but not physically coupled with the subject, (e.g., wirelessly). The second life support device 135 can include a controller to process information about the subject, including processing information monitored by first life support device 105, logistical information provided by first life support device 105, or treatment information indicative of treatment activity provided or being provided by first life support device 105 via communication path 140.” Para. [0042], “the second life support device 135 determines a course of action to follow responsive to information received from the first life support device 105. Information received from the first life support device 105 may include the date and time of any defibrillation shocks applied to the subject, the pulse width, amplitude, and energy level of those treatments, ECG and/or other information (such as pulse oxygen level, blood pressure, tidal carbon dioxide measurements, etc.) before and after treatment, etc. For example, the second life support device 135 can determine that the first life support device 105 should continue monitoring or treating the subject, or should apply a new or different treatment to the subject, e.g., defibrillation or pacing. In an embodiment, the second life support device 135 determines that a level of treatment applied by the first life support device 105 should be modified, e.g., a stronger or weaker defibrillation shock based, for example, on monitored information of the subject's response to previous treatment, or based on the subject's weight or size. The first life support device 105 can also provide information about the operating status of the first life support device 105, such as remaining available power from the power supply 130, or the time necessary before the first life support device 105 is scheduled or able to apply defibrillation therapy to the subject.” In sum, Geheb also discloses the second life support device has a monitor which the second life support medical device receives the collected and processed information of the subject from the first life support device about the clinical information, the information is transmitted by the system to identify whether to continue its treatment or apply new more advantaged life support protocol from the second life support device. Geheb discloses the second life support device has a monitor and receives clinical information about the subject to the second life support device for providing more advance treatment and operating instructions. It would be inherently required for the second life support device to display the clinical information of the subject for the ability to monitor, diagnose, and provide operating instruction),
(b) displaying on the second medical device information derived from at least some of the first clinical information (Para. [0008] and [0010], “the operating instructions from the second life support device include an instruction to apply treatment to the subject from the second life support device. The second life support device can also display the operating instructions. In an embodiment, a monitor can display the operating instructions. In some embodiments, the control unit of the first life support device can provide life support protocol information that indicates at least one of a state of the first life support device and a treatment recommendation. The control unit can receive a prompt from the second life support device to provide the life support protocol information. In some embodiments, the second life support device can control the first life support device to apply treatment from the first life support device to the subject based on the operating instructions.” Para. [0047] disclosing the second life support device receives the transmitted information including life support protocol information, subject’s ECG, cardiac or respiratory information, battery life, first life support information of battery life, monitoring or treatment capability and identifying information such as model number. The life support protocol information includes treatment recommendation which is based (i.e. derived from) on past treatment and monitored information. The life support protocol information also includes indication (which is displaying) the monitoring or treatment capability of the life support device based on (i.e. derived from) life support device model number. See Para. [0042], “the second life support device 135 determines a course of action to follow responsive to information received from the first life support device 105. Information received from the first life support device 105 may include the date and time of any defibrillation shocks applied to the subject, the pulse width, amplitude, and energy level of those treatments, ECG and/or other information (such as pulse oxygen level, blood pressure, tidal carbon dioxide measurements, etc.) before and after treatment, etc. For example, the second life support device 135 can determine that the first life support device 105 should continue monitoring or treating the subject, or should apply a new or different treatment to the subject, e.g., defibrillation or pacing. In an embodiment, the second life support device 135 determines that a level of treatment applied by the first life support device 105 should be modified, e.g., a stronger or weaker defibrillation shock based, for example, on monitored information of the subject's response to previous treatment, or based on the subject's weight or size. The first life support device 105 can also provide information about the operating status of the first life support device 105, such as remaining available power from the power supply 130, or the time necessary before the first life support device 105 is scheduled or able to apply defibrillation therapy to the subject.” The level of treatment applied to the subject is derived from the first clinical information collected. Geheb discloses the second life support device has a monitor (para. [0029]) and receives clinical information about the subject to the second life support device for providing more advance treatment and operating instructions. It would be inherently required for the second life support device to display the treatment information to the subject for the ability to monitor, diagnose, and provide operating instruction),
(c) modifying operation of the second medical device based on the first clinical information (para. [0042], “the second life support device 135 determines a course of action to follow responsive to information received from the first life support device 105. Information received from the first life support device 105 may include the date and time of any defibrillation shocks applied to the subject, the pulse width, amplitude, and energy level of those treatments, ECG and/or other information (such as pulse oxygen level, blood pressure, tidal carbon dioxide measurements, etc.) before and after treatment, etc. For example, the second life support device 135 can determine that the first life support device 105 should continue monitoring or treating the subject, or should apply a new or different treatment to the subject, e.g., defibrillation or pacing. In an embodiment, the second life support device 135 determines that a level of treatment applied by the first life support device 105 should be modified, e.g., a stronger or weaker defibrillation shock based, for example, on monitored information of the subject's response to previous treatment, or based on the subject's weight or size. The first life support device 105 can also provide information about the operating status of the first life support device 105, such as remaining available power from the power supply 130, or the time necessary before the first life support device 105 is scheduled or able to apply defibrillation therapy to the subject.”), or
(d) storing the first clinical information in the second medical device or a remote database (Para. [0043] disclosing the memory of the second life support device, may include a look-up table for associating (i.e. identifying) the features and operational capabilities supported by the first life support device, based upon the received manufacturer and model number. In para. [0046] disclosing “a life support device can include a memory unit to store information about the life support protocol. The information can include data about the type of treatment (e.g., defibrillation, pacing) and the subject's response to treatment in the form of an ECG, for example. The information can also include information about the subject, such as an estimated weight provided by the subject or by an operator of the life support device. The information can also include monitored information about one or more of the subject's cardiac or respiratory activity before, during, or after any treatment or any symptoms of a medical condition. In an embodiment, recording protocol information additionally includes recording information that identifies an operating state of at least one life support device, whether electrodes are in sufficient contact with the subject to monitor or deliver therapy with the subject, or whether the power supply is sufficiently charged to administer defibrillation therapy.” In para. [0047] disclosing the life support protocol, monitoring, and treatment information is transmitted to a second life support device. In order for the transmitted information to be received by the second life support device, the second life support has to store the received the clinical information from the first life support device. Furthermore, in para. [0054], disclosing “, the first and second life support devices are interchangeable; the first life support device can include components and characteristics described with reference to the second life support device, and the second life support device can include components and characteristics described with reference to the first life support device. The first and second life support devices can have redundant or overlapping monitoring or treatment capabilities.”); and
a graphical user interface (GUI) configured to facilitate interaction between a user and the communication component (Geheb Para. [0026], discloses a monitor 120 which includes a user interface for user input).
Geheb discloses the second life support device has a monitor and receives clinical information about the subject to the second life support device to provide more advance treatment and operating instructions. It would be inherently required for the second life support device to display the clinical information of the subject for the ability to monitor, diagnose, and provide operating instruction. Also, Geheb discloses direct P2P handoff between device 105 and device 135 via communication path 140, while a server could be involved, it is not specifically described.
Specifically, Geheb does not explicitly teach (italic emphasis):
a server device communicatively coupled to a network, the server device comprising a memory and at least one a processor communicably coupled to the memory, the memory including instructions that, when executed by the at least one processor, cause the at least one processor to initiate at least one component, the at least one component comprising:
a communication component configured to (i) facilitate network communication between the server device and a first medical device during a medical event, (ii) facilitate network communication between the server device and a second medical device during the medical event,
(a) displaying at least some of the first clinical information on the second medical device.
(b) displaying on the second medical device information derived from at least some of the first clinical information,
Nonetheless, Packer is in the analogous field of providing summary information for lifesaving activities involving defibrillator, which teaches (italic emphasis):
a server device communicatively coupled to a network, the server device comprising a memory and at least one a processor communicably coupled to the memory, the memory including instructions that, when executed by the at least one processor, cause the at least one processor to initiate at least one component (para, [0054], [0056] teaches central server system connected over network for accessing, retrieving, and storing information of the victim. In para. [0149], [0150], [0154], [0155]-[0158] and [0166] and Fig. 12 teaches server device includes processor coupled to memory for executing instruction to perform functions), the at least one component comprising:
a communication component configured to (i) facilitate network communication between the server device and a first medical device during a medical event, (ii) facilitate network communication between the server device and a second medical device during the medical event (para. [0048] teaches defibrillator 112 (first medical device) communicates with the tablet 116 (second medical device) via a short-range wireless link. Further in para. [0054] teaches the tablet 116 (and/or other devices communicates with the central server system 120 over a network 118). In para. [0056] indicates the information from the first medical device of defibrillator is uploaded to the central server system. In para. [0057] indicates the other users, such as an emergency room physician 112 with their own tablet 124 (second medical device), can then access this data from the central server. See Fig. 1A)
(a) displaying at least some of the first clinical information on the second medical device (para. [0048] teaches the tablet 116 (a second device) displays information such as ECG and compression data (first clinical information) from the defibrillator 112 (first device). Also see para. [0057] for tablet 124 (second medical device) of physician reviewing data from the central server system),
(b) displaying on the second medical device information derived from at least some of the first clinical information (Para. [0006]-[0007], [0108]-[0110], claim 1, Figs. 8 and 10 teaching generating and displaying a CPR performance metric, a weighted CPR performance metric and other derivative indicators on the tablet (second device) based on data collected by defibrillator (first device). Also see para. [0057] for tablet 124 (second medical device) of physician reviewing data from the central server system).
Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filling of the invention to modify the system for handoff of clinical information of Geheb to include the feature of advanced data aggregation and review system of Packer for displaying information on second medical device to emergency room physician (Packer para. [0057]), for the reason and motivation of providing urgent and active review of the clinical data of the patient over the network with active control over the situation when urgent and immediate care are required. Further, the claimed invention is merely a combination of old elements in a similar medical device administration field of endeavor. In such combination each element merely would have performed the same medical device administration related function as it did separately, and one of ordinary skill in the art would have recognized that, given the existing technical ability to combine the elements as evidenced by Packer, the results of the combination were predictable (See MPEP 2143 A).
Claim 23, the combination of Geheb and Packer make obvious of the system of claim 22. Geheb further discloses,
further comprising a wireless local area network (WLAN), wherein the first medical device and the second medical device are communicably coupled via the WLAN (para. [0032], “the control unit 110 of the first life support device 105 communicates information about the subject to the second life support device 135, and receives instructions from the second life support device 135 via at least one wired or wireless communication path 140. For example, communications path 140 may comprise any type interface or network such as a Universal Serial Bus (USB), local area network (LAN), Wireless LAN (WLAN)”).
however, Geheb fails to expressly teach (italic emphasis), wherein the first medical device and the second medical device are communicably coupled to the server device via the WLAN.
Nonetheless, Packer teaches, wherein the first medical device and the second medical device are communicably coupled to the server device via the WLAN (Packer [0044], [0048], discloses devices communicate over the network wirelessly. For example, the defibrillator 112 communicates with the tablet 115 via a short-range wireless data connection, and the tablet 116 communicates with the central server 120 via a wireless network.
It would have been obvious for one of ordinary skill in the art, before the effective filling of the invention to implement the wireless network of Packer’s system using WLAN technology explicitly taught by Geheb for the same purpose of connecting medical devices in a handoff scenario. This would be a simple and predictable substitution of one know type of wireless network for another to achieve reliable, high-bandwidth local communication.
Claim 24, the combination of Geheb and Packer make obvious of the system of claim 23. Geheb further discloses,
wherein one of the first and second medical devices also provides communications via the WLAN (Para. [0032]).
Claim 31, the combination of Geheb and Packer make obvious of the system of claim 22. Packer further teaches,
wherein the first clinical information details administration of cardiopulmonary resuscitation (CPR) to a patient during the medical event (Abstract, claim 1, “performance of CPR”. Paragraphs [0013], [0017], CPR performance metrics (first clinical information) can be displayed and then grades or weighted scores based upon the metrics can be provided).
Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filling of the invention to modify the system for handoff of clinical information from the first medical device to second medical device of Geheb to include the first clinical information details administration of cardiopulmonary resuscitation (CPR) to a patient during the medical event taught by Packer, for the reason and motivation of effectively and quickly provide the medical treatment to the victim for higher chance of survival (para. [0003]).
Claim 32, the combination of Geheb and Packer make obvious of the system of claim 31. Packer further teaches,
wherein the communication component is configured to display the information derived from at least some of the first clinical information on the second medical device, and wherein the information derived from at least some of the first clinical information includes an indication of CPR quality (Packer: Claim 1, para. [0007], [0012], [0019], the system generates a CPR performance metric which is a single metric indicative of overall performance of the CPR (i.e., CPR quality). In Claim 1; Fig. 5 item 502; Fig. 8, item 801; showing performance grades).
Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filling of the invention to modify the system for handoff of clinical information from the first medical device to second medical device of Geheb to include the above-mentioned feature specifically taught by Packer, for the reason and motivation of effectively and quickly provide the medical treatment to the victim for higher chance of survival (para. [0003]).
Claim 33, the combination of Geheb and Packer make obvious of the system of claim 32. Packer further teaches,
wherein the indication of CPR quality includes an indication of chest compression metrics (Packer: para. [0017], teaching CPR performance metric is generated from information about “CPR depth, CPR compression rate, and CPR fraction”).
Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filling of the invention to modify the system for handoff of clinical information from the first medical device to second medical device of Geheb to include the above-mentioned feature specifically taught by Packer, for the reason and motivation of effectively and quickly provide the medical treatment to the victim for higher chance of survival (para. [0003]).
Claim 34, the combination of Geheb and Packer make obvious of the system of claim 31. Packer further teaches,
wherein the information derived from at least some of the first clinical information includes an indication of CPR time (Packer: Claim 2, para. [0010] and [0144] teaching duration of CPR administration and CPR time interval).
Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filling of the invention to modify the system for handoff of clinical information from the first medical device to second medical device of Geheb to include the above-mentioned feature specifically taught by Packer, for the reason and motivation of effectively and quickly provide the medical treatment to the victim for higher chance of survival (para. [0003]).
Claim 35, the combination of Geheb and Packer make obvious of the system of claim 34. Packer further teaches,
wherein the indication of CPR time includes one or more of: beginning time of CPR administration, ending time of CPR administration, duration of CPR administration, or chest compression timing (Packer: Claim 2, para. [0010] and [0144] teaching duration of CPR administration and CPR time interval).
Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filling of the invention to modify the system for handoff of clinical information from the first medical device to second medical device of Geheb to include the above-mentioned feature specifically taught by Packer, for the reason and motivation of effectively and quickly provide the medical treatment to the victim for higher chance of survival (para. [0003]).
Claim 36, the combination of Geheb and Packer make obvious of the system of claim 22. Geheb further discloses,
wherein the first clinical information includes a patient ECG observed prior to the patient entering cardiac arrest (para. [0024], [0026], [0030], and [0040] disclosing monitoring subject’s electrocardiogram (ECG) to diagnose the condition for cardiac arrest and apply treatment).
Claim 37, the combination of Geheb and Packer make obvious of the system of claim 22. Geheb further discloses,
wherein the first clinical information includes a patient ECG observed after a shock is administered to the patient by the first medical device (Para. [0042], “the second life support device 135 determines a course of action to follow responsive to information received from the first life support device 105. Information received from the first life support device 105 may include the date and time of any defibrillation shocks applied to the subject, the pulse width, amplitude, and energy level of those treatments, ECG and/or other information (such as pulse oxygen level, blood pressure, tidal carbon dioxide measurements, etc.) before and after treatment, etc. For example, the second life support device 135 can determine that the first life support device 105 should continue monitoring or treating the subject, or should apply a new or different treatment to the subject, e.g., defibrillation or pacing. In an embodiment, the second life support device 135 determines that a level of treatment applied by the first life support device 105 should be modified, e.g., a stronger or weaker defibrillation shock based, for example, on monitored information of the subject's response to previous treatment, or based on the subject's weight or size. The first life support device 105 can also provide information about the operating status of the first life support device 105, such as remaining available power from the power supply 130, or the time necessary before the first life support device 105 is scheduled or able to apply defibrillation therapy to the subject.” Disclosing the first life support device deliver shocks and continue to monitor before and after treatment/shock to make adjustments).
Claim 38, the combination of Geheb and Packer make obvious of the system of claim 22. The combination further teaches,
wherein the communication component is further configured to facilitate network communication between the server device and the first medical device in response to determining the first medical device and the second medical device are proximately located (Geheb: para. [0031]-[0032], [0041] disclosing the detection the presence of the first life support device with second life support device in proximity using wired or wireless connection inducing short range Bluetooth® wireless connections. Para. [0048] disclosing the detection of the second life support device (proximately) by the first life support device. Packer [0048], [0054], [0056] teaches the network communication between the centric server and the medical devices).
Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filling of the invention to modify the automated proximity-based connection method taught of Geheb with the server centric system of Packer for the motivation of solving the aforementioned problem of slow, error-prone manual device. By implementing the feature of proximity-based connection of Geheb with server system of Packer, would ensure the server correctly associates both devices with the same patient event, improving speed, efficiency, and patient safety.
Claim 39, the combination of Geheb and Packer make obvious of the system of claim 38. Packer further teaches,
wherein the communication component is further configured to provide a prompt for confirmation on either or both of the first and second medical devices, and wherein the prompt includes at least one of a key-code, a visual beacon, a visual light, an audible prompt, or a patient specific input (Packer: Paragraphs [0043]-[0048] and [0102]-[0103] and Fig. 1A, disclosing the defibrillator 112 is connected to the victim 102 and is in short range wireless data connection with the tablet 116 using Bluetooth technology which disclosing the first and second medical devices are proximately located being used on a same patient during medical event. In light of the Application Specification paragraph [0167], “in response to a determination that the medical devices are proximate one another, one or more of the devices will prompt an indication to occur. The indication can occur visually on the medical devices' display or auditory from a speaker provided with the devices. The indication for confirmation ensures that the medical devices are authenticated for connection. Authentication can mean that both medical devices are collecting data and/or operating on the same patient. If the devices were not operating on the same patient, the exchange of clinical information may not provide an intended function. Further, more than two medical devices may be present at an emergency event (or hospital). Thus, the indication allows for a check by the device operators that the correct clinical information will be exchanged. Such an indication can be a visual code (e.g., both devices showing the same combination of lights or colors of lights), a visual beacon such as a picture, a visual light such as both devices showing the same colored light, a prompt for a key-code, an audible prompt, and/or a patient specific input such as scanning the patient's fingerprint or driver's license or other unique identifying information to ensure that the correct clinical data is exchanged between devices.” In Packer: paragraph [0049], “the processing and display of data may occur on the defibrillator 112, the tablet 116, or on both. For example, the defibrillator 112 may include a display that matches that of the tablet 116, and the two may thus show matching data. In contrast, the defibrillator 112 may have a more limited display than does the tablet 116, and might show only basic information about the technician's performance, while the tablet 116 may show more complete information such as secondary historic information. Also, the processing of primary information to obtain secondary information may be performed by the defibrillator 112, the tablet 116, or a combination of the two, and the two devices may communicate back and forth in various manners to provide to each other information they have received or processed, or to relay commands provided to them by the technician 114.” The Office asserts the command provided by the technician is an example of indication of prompt provided by the technician for the two devices to communicate and exchange information. Further in paragraph [0055], “tablet 116 or defibrillator 114 may include mechanisms so that the technicians can identify themselves and thus have their identifier stored with the information. For example, the technicians may be required to log in with the tablet 116 when their shift starts, so that all information subsequently obtained by the tablet 116 or components in communication with the tablet may be correlated to the identifier. Such logging in may require the entry of a user name and password, or may involve biometric identification, such as by the pressing or swiping of a technician's fingertip on a fingerprint reader that is built into the tablet 116.” Disclosing the ability to accept input and biometric confirmation such as fingerprint as part of the tablet or defibrillator. Furthermore, in paragraph [0088], “image 232 may be obtained from a central server system in response to entering identification information for the victim. For example, a driver's license found with the victim may indicate a name of the victim, or a fingerprint may be obtained from a fingerprint reader for the victim, where the fingerprint reader may be incorporated with a blood oxygenation sensor. Such a mechanism for identifying the victim may be used to recover limited medical record information about the victim, such as the blood type, allergies and medications taken by the victim. The image 232 may be displayed so that the rescuer may manually confirm that the patient who is identified by the system is the same person as the victim who is lying front of them (where the victim is unable to identify himself or herself).”
Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filling of the invention to modify the system for handoff of clinical information from the first medical device to second medical device of Geheb to include the feature of providing prompt for confirmation to allow the handoff of information, specifically taught by Packer, for the reason and motivation of properly confirming the two medical devices are being used on the same victim and prevent the possible of mismatch of information (Packer, para. [0088]).
Claim 40, the combination of Geheb and Packer make obvious of the system of claim 38. Packer further teaches,
wherein the communication component is further configured to determine the first medical device and the second medical device are proximately located in response to exchange of radio frequency signals (paragraph [0160], communication between the devices of the system may include radio signals through a radio-frequency transceiver).
Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filling of the invention to modify the system for handoff of clinical information from the first medical device to second medical device of Geheb to include the above-mentioned feature specifically taught by Packer, for the reason and motivation of effectively and quickly provide the medical treatment to the victim for higher chance of survival (para. [0003]).
Claim 41, the combination of Geheb and Packer make obvious of the system of claim 38. Packer further teaches,
wherein the communication component is further configured to determine the first medical device and the second medical device are proximately located in response a receipt of a global positioning system (GPS) signal from each of the first medical device and the second medical device (para. [0160], system includes a GPS to provide location information of the devices of the system).
Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filling of the invention to modify the system for handoff of clinical information from the first medical device to second medical device of Geheb to include the above-mentioned feature specifically taught by Packer, for the reason and motivation of effectively and quickly provide the medical treatment to the victim for higher chance of survival (para. [0003]).
Claim 42, the combination of Geheb and Packer make obvious of the system of claim 38. Packer further teaches,
wherein the communication component is further configured to determine the first medical device and the second medical device are proximately located in response to each of the first medical device and the second medical device being connected to a shared local area network (LAN) (Para. [0166], devices of the system may be interconnected by any form of digital data communication including a local area network).
Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filling of the invention to modify the system for handoff of clinical information from the first medical device to second medical device of Geheb to include the above-mentioned feature specifically taught by Packer, for the reason and motivation of effectively and quickly provide the medical treatment to the victim for higher chance of survival (para. [0003]).
Claim 44, the combination of Geheb and Packer make obvious of the system of claim 22. Packer further teaches,
wherein the communication component is further configured to facilitate network communication between the server device and the first medical device in response to determining a correlation between the first clinical information and information about one or a combination: an identity of a patient treated with the second medical device (Para [0045]-[0048]. [0078], and [0088] disclosing the defibrillator 112 provides sensor on the victim 102. Fingerprint obtained from a fingerprint reader and blood oxygen level from blood oxygenation sensor attached from defibrillator on the victim incorporated with driver’s license information entered on the tablet 116 are used together to identify the victim/patient of the event), a location of the patient or the second medical device (para. [0160] teaches GPS to provide location information of the devices of the system), a time (Para. [0056]-[0059], [0066], [0070], [0121], disclosing the time stored for the treatment), an identity of a caregiver (para. [0054]-[0055], identity of the caregiver is determined based upon the logging in using biometric information;), or second clinical information gathered by the second medical device.
Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filling of the invention to modify the system for handoff of clinical information from the first medical device to second medical device of Geheb to include the above-mentioned feature specifically taught by Packer, for the reason and motivation of effectively and quickly provide the medical treatment to the victim for higher chance of survival (para. [0003]).
Claim 72, the combination of Geheb and Packer make obvious of the system of claim 22. Geheb further discloses,
wherein at least one of the first medical device or the second medical device is bodily-attached to a patient involved in the medical event (Geheb, [0034] and Fig. 2 describes a first life support device 105 that is a wearable therapeutic or monitoring device associated with at least one garment 205 worn by the subject).
Packer also teaches, wherein at least one of the first medical device or the second medical device is bodily-attached to a patient involved in the medical event (Packer, [0046] teaches accelerometer assembly 110 which is mounted on the center of the electrodes and positioned on the patient’s chest to measure CPR compressions).
Claims 26, 30, and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Fan et al. (US), hereinafter Geheb (US 2014/0005736 A1), hereinafter “Geheb,” in view of Packer et al. (US 2014/0365175 A1), hereinafter “Packer,” and further in view of Jelatis et al. (US 2008/0244717 A1), hereinafter “Jelatis.”
Claim 26, the combination of Geheb and Packer make obvious of the system of claim 24. However, the combination fails to expressly teach, 28
wherein the one of the first and second medical devices is also a communications router on the WLAN.
However, Jelatis which is directed to a system and method for confirming identity and authority by a patient medical device, which specifically teaches:
wherein the one of the first and second medical devices is also a communications router on the WLAN (Jelatis teaches the patient medical devices and monitors (PMDs) are capable of being remotely interrogated or programmed using a PID, which describes using a locally situated personal communicator 19 or an antenna point that serves as an RF repeater to extend telemetric range. In this case, the RF repeater functions as a router, relaying signals).
Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filling of the invention to have modified the medical life support system of Geheb providing communication over WLAN to include the feature of the one of the first and second medical devices is also a communications router on the WLAN, as taught by Jelatis for the motivation and the advantage of ensuring the security of patient data and that the medical devices are only prompted by trustworthy medical professionals or other predetermined authorized users (Jelatis, paragraph [0019]).
Claim 30, the combination of Geheb and Packer make obvious of the system of claim 24. However, the combination fails to expressly teach,
wherein the WLAN is dynamically reconfigurable and secure.
However, Jelatis which is directed to a system and method for confirming identity and authority by a patient medical device, which specifically teaches:
wherein the WLAN is dynamically reconfigurable and secure (Jelatis Para. [0020] teaching the use of protocols like Bluetooth and Wifi which describes dynamically reconfigurable protocols designed for ad-hoc connections for dynamically reconfigurable connection. In para. [0032] teaches the system using digital credentials, public key cryptographic system and digital signatures to ensure that the communication channel is secure and trusted).
Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filling of the invention to have modified the medical life support system of Geheb providing communication over WLAN to include the feature wherein the WLAN is dynamically reconfigurable and secure, as taught by Jelatis for the motivation and the advantage of ensuring the security of patient data and that the medical devices are only prompted by trustworthy medical professionals or other predetermined authorized users (Jelatis, paragraph [0019]).
Claim 46, the combination of Geheb and Packer make obvious of the system of claim 22. However, the combination fails to expressly teach,
wherein the communication component is further configured to authenticate one or both of the first and second medical devices.
However, Jelatis which is directed to a system and method for confirming identity and authority by a patient medical device, which specifically teaches:
wherein the communication component is further configured to authenticate one or both of the first and second medical devices (Abstract, claim 1, para. [0007], [0019]. Para. [0021] system and method for confirming identity and authority on a medical device, such as defibrillator, requires use of a public key and is based on a certification authority, further teaching interconnect of information is provided over a network in conventional wired, wireless, or various combinations of interconnectivity).
Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filling of the invention to have modified the system of Geheb and Packer using LAN connectivity of information to further include the authentication, as taught by Jelatis, for the advantage of ensuring the security of patient data and that the medical devices are only prompted by trustworthy medical professionals or other predetermined authorized users (Jelatis, paragraph [0019]).
Response to Remarks
35 U.S.C. 101 Rejections:
The Applicant’s remarks are fully considered, however are found to be unpersuasive.
The Applicant asserts the claims do not set forth or describe “assessing client risk.” The Applicant further asserts claims 22 recites a system for “clinical data handoff” that comprises a server device that is communicatively coupled to a network.
The Examiner respectfully disagrees. The Office Action has carefully addressed each and every claim limitations, individually and in combination. The claimed invention recites a clinical data handoff with application of medical computing devices and server device for communication. However, the Office asserts the claim recites the functions of the clinical data handoff from communication is directed to and for the purpose of monitoring and assessing patient risk during a medical event, which the steps (functions) of collecting clinical/medical information, presenting the collected information, performing operation as result of the information collected and storing the collected information during a medical event have been practices capable and perform by medical professionals before the invention of medical devices and computer systems. The medical/computer system and service device in the claimed invention is only used for the purpose of transmitting and communicating information for the purpose of monitoring and assessing patient condition and risk. As indicated in the 101 rejection above, the steps of communicating, receiving, displaying, and storing information are steps of adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea as discussed in MPEP 2106.05(f).
Thus, the 101 rejection is maintained in view of the amendment.
35 U.S.C. 103 Rejections:
The Examiner asserts that the applicant’s arguments are directed towards amended claim limitations and are, therefore, considered moot. However, the Examiner has responded to the amended amendments, which the arguments are directed to, in the rejection above, thereby addressing the applicant’s arguments. Although the arguments are deemed moot, the Examiner will rephrase the response below,
The Applicant asserts the references do not teach the amended claim limitation of “facilitate network communication between the server device and a first medical device during a medical event” and “facilitate network communication between the server device and a second medical device during the medical event” (original emphasis in remarks).
The Examiner respectfully disagrees. While Geheb discloses peer to peer handoff between devices via communication network, and device act as a server, Geheb does not disclose a separate server device. However, Packer’s system is directed to a central server system 120 (para. [0054]). In particular Fig. 1A describes a first medical device of defibrillator and tablet 116 communication to network (para. [0048], [0054]) and tablet 124 access data from central server (para. [0057]).
Thus, the 103 rejection is maintained in view of the amendment.
Relevant Prior Art Not Relied Upon
The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure. The additional cited art, including but not limited to the excerpts below, further establishes the state of the art at the time of Applicant’s invention and shows the following was known:
Lowe et al. (US 20130013033 A1) is directed to a system includes a therapy wrap and a first therapy device for exchanging heat with the body. The system may include a second therapy device for delivering another therapy. The first therapy device may include a heat transfer device, a cooling or heating source, and a control unit. The heat transfer device may include a fluid bladder and a compressive bladder. The second therapy device may be an electric stimulation device. The therapy wrap is adapted to coordinate delivery of the thermal therapy and another therapy to the animate body. The therapy wrap may also be a sleeve for mounting components of the first and second therapy devices. Also disclosed are a method of administering a temperature-controlled treatment to an anatomical body part and method of making the therapy system.
Jamali, Jay. "Automated External Defibrillator (AED) Deployment: What to Do Before, During and After." Paper presented at the ASSE Professional Development Conference and Exposition, New Orleans, Louisiana, June 2005.
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 nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WENREN CHEN whose telephone number is (571)272-5208. The examiner can normally be reached Monday - Friday 10AM - 6PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nathan C Uber can be reached on (571) 270-3923. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/WENREN CHEN/Examiner, Art Unit 3626