DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Notice to Applicant
Receipt of Applicant’s Amendment filed November 18, 2025 is acknowledged.
Response to Amendment
Claims 1, 3-5, and 8 have been amended. Claims 2 and 6-7 have been cancelled. Claims 1, 3-5, and 8 are pending and are provided to be examined upon their merits.
Response to Arguments
Applicant’s arguments filed November 18, 2025 have been fully considered but they are not persuasive. A response is provided below.
Applicant argues 35 U.S.C. §112 Rejections, pg. 8 of Remarks:
Examiner acknowledges Applicant amendment. However, the term “QR” itself is a trademarked term (US Serial Number: 86119014). Thus, the rejection is maintained.
Examiner notes that Applicant amendments have introduced further 112 rejections. See below.
Applicant argues 35 U.S.C. §101 Rejections, pg. 9 of Remarks:
Regarding Applicant argument that the claims “collectively provide a concrete and technological solution to a long-standing problem in the medical-device field – how to securely transfer vital-sign data form devices that cannot use wireless connectivity due to regulatory and safety constraints”, Examiner notes that regulatory and safety constraints are related to an abstract method of organizing human activity as legal interactions. Thus, the solution provided is directed to solving a problem that is abstract in nature, not technical.
Regarding Applicant argument that the claimed combination of (1) pixel-modulated optical encoding, (2) checksum verification, and (3) secure intranet communication provides significantly more than any alleged abstract idea, Examiner respectfully disagrees.
Regarding (1), Applicant specification does not explicitly support modulation of pixels by a code generation controller. However, pixel modulation by a digital code generator is standard for digital code generation and does not represent an improvement over other digital code generation methods in the field. One of ordinary skill of the art would understand that a digital QR code generator would modulate the pixels on a screen to output a generated digital QR code, as evidenced by Sutheebanjard (Sutheebanjard; Phaisarn, QR-Code Generator, 2010, Eighth International Conference on ICT and Knowledge Engineering), pg 1: “If we copy http://goo.gl/H3xr into a new browser window and append “.qr” to the end of the link as: http://goo.gl/H3xr.qr, the QR code will be shown as in Fig. 2.” It would be obvious that this digital method of generating a QR code would modulate the pixels of the display output to display the generated QR code.
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Regarding (2), error-correction checksum verification is also not explicitly supported within Applicant specification. However, they are a standard feature of QR codes, and their inclusion in the claims does not provide an improvement over other types of QR codes.
Evidence is provided by CSFieldGuide, Coding - Error control 9.4. QR codes, 4 Mar 2022, CSFieldGuide.
Pg. 2 recites: “When one bit is changed (either white to black, or black to white), it’s easy for the software to detect that this has happened, and it can change it back. However, QR codes use a stronger error control code than the parity trick; even if you change several bits, it can usually work out the original message. This is error correction at work.”
Pg. 4 recites: “A Universal Product Code (UPC) standard was developed that included a check digit to make scanning reliable, and this time an error detection checksum was used based on multiplying every second digit by 3… Because QR codes can store so much more data, it is a lot easier to add error correction bits to them, so they are capable of Forward Error Correction. This in turn has made them useful in places where they might be subject to wear and tear - printed on paper, stuck on notice boards, windows, and places that are exposed to the elements.”
Further evidence is provided by Fast Reports; How to create a QR code with a picture, 9 Jan 2019, Fast Reports, which recites, on pg. 1: “The technology of QR codes contains redundancy (duplication of information) and a checksum. Therefore, even with 30 percent code corruption, it can be read. And the checksum ensures that it is read correctly.”
Regarding (3), usage of a secure internal hospital network simply describes a high level, generic usage of any secure internal hospital network. The inclusion of such a feature does not provide an improvement over similar system as any generic secure internal hospital network is applied to perform the insignificant extra-solution activity of transmitting data (pg. 14 of Applicant specification, “the communication part 220 may transmit the measurement data securely by using a hospital internal network in which a firewall and a security system are installed. Herein, the network used by the communication part 220 may be realized as a wired network, such as a local area network (LAN), a wide area network (WAN), or a value added network (VAN), or as any type of a wireless network, such as a mobile radio communication network, a satellite communication network, Bluetooth, a wireless broadband Internet (Wibro), High Speed Downlink Packet Access (HSDPA), long-term evolution (LTE), or 3/4/5/6th generation mobile telecommunication (3/4/5/6G).”).
Thus, Examiner respectfully maintains the 35 U.S.C. 101 rejection.
Applicant argues 35 U.S.C. §103 Rejections, pg. 7 of Remarks:
Regarding non-wireless operation, Applicant argues that McKirdy in view of Mrowiec does not teach the amended claim limitations as both rely on consumer mobile or network-connected devices. Examiner respectfully disagrees. [0050] of McKirdy recites: “The invention also contemplates being able to use a stand-alone device that is in signal communication with the exercise machine either through a hardwired or wireless connection (or both) where the stand-alone device (being referred to also as a information processing and generation module) can retrieve the exercise and machine performance information (such as through serial communication with the exercise machine).” A stand-alone device that only communicates with a patient-measurement device through wired means, as supported by McKirdy, teaches an entirely non-wireless device that is isolated from any network connection (internet).
Regarding optical code with integrity fields, Applicant argues that Mrowiec does not teach the inclusion of integrity fields (error correction checksum verification) to ensure verifiable offline data transfer. However, as demonstrated above, checksums are a part of QR codes, as evidenced by CSFieldGuide, Coding - Error control 9.4. QR codes, 4 Mar 2022, CSFieldGuide and Fast Reports; How to create a QR code with a picture, 9 Jan 2019, Fast Reports, as shown above. Thus, any system that utilizes QR codes in any way will include integrity fields. Examiner again notes that Applicant specification does not explicitly recite or support checksums.
Regarding secure internal hospital network only, Examiner notes that recitation of wired and wireless options for network communication does not preclude the option of only using wired means to communicate ([0037] of Cardarelli, “In a medical facility with an electronic medical record (EMR) system, an EMR process 154 executes on computer 152 connected to network 150. The network is any local area network (LAN), or wide area network (WAN) well known in the art, with wired communication links or wireless communication links or both.”). Thus, Examiner respectfully maintains the rejection.
Regarding automatic chart population, Examiner notes that neither Browne nor Smith are relied upon to teach the claimed feature. Thus, Examiner maintains that uploading decoded measurement data to a remote server for record keeping, such as in an electronic medical record, as taught by McKirdy teaches the claim limitation.
Regarding audit tracking and regulatory compliance, Examiner agrees with Applicant and new art has been applied. Examiner notes that Applicant specification also does not support maintaining a verified audit log of each upload event.
Regarding B, Applicant argues that there is no motivation to combine the two references as the continuous network connectivity of Cardarelli would destroy the intended functions and would not yield the presently claimed offline optical-to-intranet system and is representative of impermissible hindsight reconstruction. Examiner respectfully disagrees, Cardarelli is simply applied to teach wherein the network between the user terminal and the server (as taught by Fig. 1 of McKirdy, red box below) may be a secure internal hospital network. As Cardarelli is applied to further define the type of network being used and is not relied upon for any continuous network connectivity, as is argued by Applicant, Examiner maintains that the resulting combination is valid.
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Regarding C, Examiner reminds Applicant that the statutory basis of 35 U.S.C. 103 is as follows: “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.”
As such, the ability to garner international recognition, receive awards, and attract investment proposals are not considered under 35 U.S.C. 103.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitations uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are:
“code generation controller” recited in claim 1
“code recognition module” recited in claim 1
“chart application” recited in claim 1
“code recognition unit” recited in claim 3
“web server module” recited in claim 8
For the purposes of examination, Examiner will interpret each element to be software modules enacted by computing devices that perform their respective functions as Applicant specification does not provide sufficient support for these elements being hardware.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 4, 5, and 8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 4 introduces a language unsupported by Applicant specification including: “audibly or visually notify a user when the checksum verification result indicates a decoding error or data mismatch; and restrict any external data sharing such that the decoded measurement data can be output or transmitted only within the secure internal hospital network.” The only notification supported by Applicant specification is described on pg. 10, which recites: “That is, the server 300 may store a patient’s basic information and vital information for each patient for patient monitoring, and may monitor the vital information to notify a medical worker of occurrence of an emergency or a special issue through the user terminal 200.” This feature is related to the vital information of the patient rather than any checksum verification result indicating a decoding error or data mismatch. Applicant specification also does not support restricting communications of a user terminal device.
Claim 5 has been amended to recite “receive,…, a print command through a short-range wired or limited-range local interface that does not provide Internet or network access”. However, Applicant specification clarifies that the only supported communication mechanism with the code printing device is Bluetooth wireless communication, which is not a wired interface (Pg. 11, lines 3-8, of Applicant specification recite: “The code printing device 400 may be connected to the patient measurement device 100 through Bluetooth wireless communication, and may receive a printing signal to print a 1D or 2D code 1 generated by a code generator 130 of the patient measurement device 100. That is, the code printing device 400 may receive a printing signal from the patient measurement device 100 to print a code 1 on paper,”). Any mention of wired networks is only with regards to the hospital internal network (pg. 14, lines 5-9, “the communication part 220 may transmit the measurement data securely by using a hospital internal network in which a firewall and a security system are installed. Herein, the network used by the communication part 220 may be realized as a wired network,”).
Claim 8 introduces “wherein the server further records each data upload event and access log for audit tracking to ensure data integrity and regulatory compliance in accordance with medical device approval protocols.” Access log creation for audit tracking is not supported by Applicant specification.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3-5, and 8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is found to be indefinite for multiple reasons:
Claim 1 recites: “wherein the patient measurement device is entirely non-wireless and isolated from any external network connection”. Examiner notes that the patient measurement device cannot be isolated from any external network connection as (1) it is capable of connecting to a code printing device, which is an external device that the patient measurement device can communicate with using an external network connection, and (2) any device capable of capturing data from the QR code displayed on the patient measurement device, such as the user terminal, constitutes an optical external network connection. For the purposes of examination, Examiner will interpret the patient measurement device as being a device that cannot communicate via the internet.
Furthermore, the phrase "for example"/”e.g.” renders the claim indefinite because it is unclear whether the limitation following the phrase (QR-type code) is part of the claimed invention. See MPEP § 2173.05(d).
Claim 1 contains the trademark/trade names “QR”, “ISO”, and “IEC” (US Serial Numbers: 86119014; 79001732; and 79081305, respectively). Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a one dimensional or two dimensional code and, accordingly, the identification/description is indefinite.
Claim 1 recites “a server exclusively through a secure internal hospital network” and “a server configured to receive, store, and associate the transmitted data with a patient record”. It is indefinite as to if these two servers are the same or if the second recited server represents a second server. For the purposes of examination, Examiner will interpret the two servers to be one single server, as shown in Fig. 1 of Applicant drawings.
Claims 3-5 and 8 are rejected by virtue of their dependency on claim 1.
Claim 3 recites “wherein the code recognition module comprises:” “a communication unit configured to transmit the decoded measurement data to the server only through the secure internal hospital network without any Internet connection”, which suggests that the code recognition module comprises the communication unit. It is indefinite as to if the communication unit is part of the code recognition module or is a separate element within the user terminal. Claim 1 describes the communication interface (which performs the same function as the communication unit) as being a separate element from the code recognition module.
Claim 4 is further rejected by virtue of its dependency on claim 3.
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 1, 3-5, and 8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Subject Matter Eligibility Criteria – Step 1:
The claims recite subject matter within a statutory category as a process and a machine
(claims 1, 3-5, and 8). Accordingly, claims 1, 3-5, and 8 are all within at least one of the four statutory categories.
Subject Matter Eligibility Criteria – Step 2A – Prong One:
Regarding Prong One of Step 2A of the Alice/Mayo test, the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. MPEP §2106.04(II)(A)(1). An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and /or c) mathematical concepts. MPEP §2106.04(a).
The Examiner has identified system Claim 1 as the claim that represents the claimed invention for analysis.
Claim 1:
A patient monitoring system using optical code recognition comprising:
a patient measurement device comprising:
a measurement sensor configured to measure vital signs of a patient;
a display configured to present the measured vital signs;
a code generation controller configured to modulate luminance of display pixels to generate a machine-readable optical code,
wherein the optical code comprises a patient identifier, measurement data, a measurement timestamp, and an error-correction checksum,
wherein the optical code is one of a one-dimensional barcode or a two- dimensional matrix code compliant with ISO/JEC 18004 (e. g., QR-type code); and
wherein the patient measurement device is entirely non-wireless and isolated from any external network connection;
a user terminal physically separate from the patient measurement device, comprising:
a camera configured to capture the optical code from the display;
a code recognition module configured to decode the captured optical code into measurement data;
a communication interface configured to transmit the decoded measurement data to a server exclusively through a secure internal hospital network; and
a chart application configured to automatically populate an electronic patient chart with the decoded measurement data based on the patient identifier; and
a server configured to receive, store, and associate the transmitted measurement data with a patient record,
wherein the patient monitoring system enables secure offline transmission of vital signs from the non-wireless patient measurement device to the hospital network via optical code capture, thereby improving data integrity, cybersecurity, and device approval compliance in medical environments where radio transmission is restricted.
These above limitations, under their broadest reasonable interpretation, cover performance of the limitation methods of certain methods of organizing human activity. Pg. 2, lines 19-23 of Applicant specification recites: “it is necessary to develop a technology that allows an attending doctor or nurse to check a patient’s state in real time anytime and anywhere, and allows the patient’s data to be updated and monitored in real time after the doctor’s or nurse’s rounds”. The present claims cover certain methods of organizing human activity as managing personal behaviors or interactions of medical staff as checking patient vitals and storing vital sign data could otherwise be performed by medical staff. The claim further requires medical staff to interact with patient monitoring devices (scanning using the user terminal) as well as monitoring patients for their data. As noted in Applicant Remarks submitted on July 29, 2025, the claims, as a whole, are also directed towards avoiding regulatory restrictions on wireless communication of data, which encompasses the legal interactions sub-grouping.
Accordingly, the claim recites at least one abstract idea.
Subject Matter Eligibility Criteria – Step 2A – Prong Two:
Regarding Prong Two of Step 2A of the Alice/Mayo test, it must be determined whether the claim as a whole integrates the idea into a practical application. As noted at MPEP §2106.04 (ID)(A)(2), it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.” MPEP §2106.05(I)(A).
Additional elements cited in the claims:
a patient measurement device, a measurement sensor, a display, a code generation controller, display pixels, a machine-readable optical code, a user terminal, a camera, a code recognition module, a communication interface, a server, a secure internal hospital network, a chart application (1); a code recognition unit, a communication unit (3); an output module, a graphical user interface (4); a code printing device, a short-range wired or limited-range local interface (5); a server computer, a web server module (8)
The independent claim recites insignificant extra-solution activities performed by the secure internal hospital network, server, and chart application such as receiving, storing, and transmitting data. Please see 2106.05(g).
Any computing devices that would be able to perform the method (user terminal, server, server computer) are taught at a high level of generality such that the claim elements amounts to no more than mere instructions to apply the exception using any generic component capable of performing the claim limitations. Pg. 10, lines 9-10 of Applicant specification recites: “the user terminal 200 may be realized by connecting a code reader capable of recognizing a 1D or 2D code 1 to a PC, a portable terminal, or a server computer 310, which are used for patient management in a hospital.” Pg. 15, line 19 of Applicant specification further recites: “a server 300 may include a server computer 310 and a web server 320.” No specific, technical improvements are being made to medical information processing device as generic devices are simply being used to perform the abstract idea.
The code and related encoding mechanisms (machine-readable optical code, code generation controller) are also taught at a high level of generality. Pg. 12, lines 7-8 of Applicant specification recite: “the code 1 generated by the code generator 130 may be either a 1D code 1 (barcode) or a 2D code 1 (QR code).” No specific, technical improvements are being made to the field of cryptography, as generic code generation mechanisms are simply applied to aid in performance of the abstract idea of avoiding legal regulation.
The code recognition part, camera, and light sensor are also taught at a high level of generality. Pg. 11, lines 3-8, of Applicant specification recite: “The code recognition part 210 may recognize a 1D or 2D code 1 using light or a camera. More specifically, the code recognition part 210 may be realized as a camera or a web cam provided in a portable terminal, such as a smartphone or a tablet PC, or may be configured as a code reader for recognizing a code 1 by emitting light and detecting reflected light.” No specific, technical improvements are being made to these devices, as existing solutions are simply being applied.
The patient measurement device comprising the measurement sensor is taught at a high level of generality. Claim 2 recites: “the patient measurement device (100) is at least one selected from a group of a pulse oximeter, a sphygmomanometer, a thermometer, an ECG meter, and a glucose meter.” No specific, technical improvements are being made to these devices, as they are simply used to perform the insignificant extra-solution activity of collecting data.
Display devices (display, display pixels, output module, graphical user interface) are also taught at a high level of generality. Pg. 11-12, lines 25-1, of Applicant specification recite: “The display 120 may display the measured vital information. More specifically, the display 120 may be realized as a display panel for displaying measurement results of the measurement part 110, and may be configured to display the most recently measured results.” No specific, technical improvements are being made to display devices, as they are simply used to perform the insignificant extra-solution activity of outputting data for visualization.
The code printing device and short-range wired or limited-range local interface are also taught at a high level of generality. Pg. 11, lines 3-8, of Applicant specification recite: “The code printing device 400 may be connected to the patient measurement device 100 through Bluetooth wireless communication, and may receive a printing signal to print a 1D or 2D code 1 generated by a code generator 130 of the patient measurement device 100. That is, the code printing device 400 may receive a printing signal from the patient measurement device 100 to print a code 1 on paper,” No specific, technical improvements are being made to these devices, as they are simply used to perform the insignificant extra-solution activity of transmitting data and generically printing information.
The communication networks (communication interface, secure internal hospital network, communication unit) are also taught at a high level of generality. Pg. 14, lines 7-14, of Applicant specification recite: “the network used by the communication part 220 may be realized as a wired network, such as a local area network (LAN), a wide area network (WAN), or a value added network (VAN), or as any type of a wireless network, such as a mobile radio communication network, a satellite communication network, Bluetooth, a wireless broadband Internet (Wibro), High Speed Downlink Packet Access (HSDPA), long-term evolution (LTE), or 3/4/5/6th generation mobile telecommunication (3/4/5/6G).” No specific, technical improvements are being made to communication networks as any network can be applied to perform the insignificant extra-solution activity of transmitting data.
The chart application is also taught at a high level of generality. Pg. 15, lines 4-13 of Applicant specification recite: “More specifically, the user terminal 200 may communicate with the server 300 to run a chart application for recording and managing a patient’s chart, and may record the patient’s chart using a result of recognizing the code 1. In this way, a chart application program installed on a portable terminal or a patient management PC may be used to automatically input the measurement data recognized by the code recognition part 210 in accordance with a patient identification number to record the chart, thereby enabling easy, fast, and accurate chart recording and management.” No specific, technical improvements are being made to chart applications, as any generic chart application is applied to perform the abstract idea of managing patient health data.
The web server module is also taught at a high level of generality. Pg. 16, lines 1-7 of Applicant specification recite: “The web server 320 may use a communication network to provide monitoring data to a user terminal 200. The web server 320 may provide the monitoring data stored in the server computer 310 to a user terminal 200 and a patient management PC of a hospital over the network, and may automatically record a chart using the measurement data and provide statistical information through a chart application program.” No specific, technical improvements are being made to web servers as it is simply being applied to perform the insignificant extra-solution activities of outputting data to user terminals and storing data in a chart.
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Looking at the additional elements as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole with the limitations reciting the at least one abstract idea, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole does not integrate the abstract idea into a practical application of the abstract idea. MPEP §2106.05(I)(A) and §2106.04(IID)(A)(2).
The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set forth below:
Claim 3: This claim recites wherein the code recognition module comprises: a code recognition unit configured to recognize and decode the optical code captured by the camera using an image-processing or pattern-analysis algorithm stored in the user terminal; and a communication unit configured to transmit the decoded measurement data to the server only through the secure internal hospital network without any Internet connection, wherein the user terminal performs local decoding without reliance on external cloud services and automatically verifies the checksum included in the optical code before transmission to ensure data integrity; which teaches code recognition using light or a camera at a high level of generality, such that the claimed method provides no specific, technical improvements over other systems that also decode one or two dimensional codes.
Claim 4: This claim recites wherein the user terminal further comprises an output module configured to: display the decoded measurement data together with the patient identifier and measurement timestamp on a graphical user interface of the user terminal; audibly or visually notify a user when the checksum verification result indicates a decoding error or data mismatch; and restrict any external data sharing such that the decoded measurement data can be output or transmitted only within the secure internal hospital network; which teaches a display and data transmission restriction at a high level of generality, such that no specific, technical improvements are provided by their application. Furthermore, a notification to a user encompasses an abstract idea as providing information to a person.
Claim 5: This claim recites further comprising a code printing device configured to: receive, from the patient measurement device, a print command through a short-range wired or limited-range local interface that does not provide Internet or network access; and print the machine-readable optical code generated by the code generation controller, wherein the printed optical code includes the patient identifier, measurement timestamp, and checksum, and can be physically attached to a patient chart or specimen label within the hospital facility for offline record keeping; which teaches a printing device and wireless communication at a high level of generality such that they are simply applied to perform the insignificant post-solution activity of printing a code.
Claim 8: This claim recites wherein the server comprises: a server computer configured to receive, store, and manage the measurement data transmitted from the user terminal exclusively within a secure internal hospital network that is physically and logically isolated from the Internet; and a web server module configured to provide monitoring data to authorized user terminals through authenticated sessions and encrypted communication channels, wherein the server further records each data upload event and access log for audit tracking to ensure data integrity and regulatory compliance in accordance with medical device approval protocols; which teaches an abstract idea of monitoring data access and providing an audit log. This claim further teaches the server computer, user terminals, and the secure internal hospital communication network at a high level of generality, such that they are only applied to perform the abstract idea of monitoring data access and insignificant extra-solution activities of gathering, storing, and transmitting data.
Subject Matter Eligibility Criteria – Step 2B:
Regarding Step 2B of the Alice/Mayo test, representative independent claims do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
These claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field use. Additionally, the additional limitations, other than the abstract idea per se, amount to no more than limitations which:
Amount to elements that have been recognized as activities in particular fields (such as Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information), MPEP §2106.05(d)(II)(i);storing and retrieving information in memory, Versata Dev. Group, MPEP §2106.05(d)(II)(iv)).
Measurement devices without real-time wireless communication, usage of codes to transmit patient data, and automated charting softwares are known:
Using codes to transmit patient data derived from measurement devices without real-time wireless communication:
McKirdy (US 20130032634) recites: [0069], “Furthermore, the sensory hardware and the exercise device, and/or the sensory hardware and the secondary processing module, and/or the secondary processing module and the exercise machine may be communicated via at least one of a hard wired and/or wireless communication.” [0071], “in the event the mobile health device (such as a glucometer) does not have the ability to generate/display a barcode in the traditional `white/black` format due to an LCD screen display, the method of the present invention includes the ability to have use traditional 2D barcodes. For example, the mobile health device might also be used for scanning traditional barcodes.” [0065], “In one situation, a person might use a glucometer for monitoring their blood sugar levels, where the glucometer may be able to generate and display a barcode that is generated in response to the user's blood glucose measurement. As discussed herein the generated barcode can be uploaded (i.e. scanned or email/text (image)) using any mobile device. This is beneficial because although there are companies that provide BlueTooth enabled glucometer products, there is still a large challenge in how these devices can communicate with mobile devices due to several reasons, such as mobile device 3.sup.rd party software development restrictions and limits of data sharing on those devices with 3.sup.rd party hardware devices. The present invention allows a person to easily transfer their data simply by scanning a barcode that is generated in response to their measurements to a mobile device or other processing device.”
Mrowiee (US 20070145137) recites: [0031], “some medical measuring apparatus may be operable to perform only one or few types of medical measurement and generate medical data having a fixed number of digits. Such apparatus may include, but are not limited to, digital thermometers, blood pressure and blood sugar analyzers, or the like. Thus, a digital thermometer, for example, may be configured in accordance with one embodiment of the present invention to display the measured temperature data, which may have only five significant digits: three whole digits and two decimal digits, using a default linear symbology, such as a Code 39 symbology. Alternatively, the thermometer may be configured to display measured temperature data using a default Code 128 symbology, or the like.” Examiner notes that the output is only described as being displayed using a code, and not communicated using wireless means.
Examiner emphasizes that reciting embodiments for using wireless and wired communications does not preclude the embodiment of only using the non-wireless means of communication, and is, therefore, analogous to a measurement device without real-time wireless communication.
Regarding usage of codes to transmit patient data:
Howell (US 6215992) recites: Col. 7, lines 12-15, “Examples of bar code data employed in the health care industry includes those relating to: a patient's ID number; chart of vital signs; medicine containers; EKG graphs; X-ray films; and vials of blood and other body fluids.”
Hold (US 20140278552) recites: [0111], “When a physician accesses a patient profile from a dashboard, he is also presented with a QR code. He can capture this QR code with a portable device such as a smart phone, a tablet or other similar device using an application such as SCAN LIFE. Once decrypted by the portable device, the QR code causes predetermined patient specific information to be downloaded to the physician's device such as the patient's latest vital signs (e.g., weight, blood pressure heart rate, medications he is taking, compliance or non-compliance with his medicine regimen, etc.)”
Ponnambalam; Mathivanan, QR code based patient data protection in ECG steganography, 5 November 2018, Australasian Physical & Engineering Sciences in Medicine, recites: Pg. 1057, “Current work investigates ECG steganography using Discrete Wavelet Transform (DWT) and Quick Response (QR) code. Steganography deteriorates the ECG signal and it is important to minimize this deterioration to preserve diagnosability. 1D ECG signal is converted to 2D ECG image and decomposed into sub-bands by subjecting it to DWT. The novelty of the proposed approach lies in converting the patient data into QR code and using it as watermark in ECG steganography.” Pg. 1059 further clarifies that ECG is a vital sign: “Electrocardiogram (ECG) signal is a record of heart’s electrical activity.”
Regarding automated charting software:
Browne (US 20030216974) recites: [0084], “Once the drug sample identifier and patient identifier have been entered, the information regarding the dispensing of that drug sample and the patient to which the drug sample was dispensed is automatically saved to the system in the medical center sample tracking database 107, patient dispensed database 117, inventory software 175, and patient charting software 180, thereby eliminating the need for the medical staff member to fill out any paper forms, make any entries in an inventory log, or make any entry in a patient chart.”
Smith; Laura, Reducing Errors Through Automated Vital Signs Data Upload, Sep 2009, CIN: Computers, Informatics, Nursing, 27(5):p 318-323 recites: Pg. 318, “This study evaluated the impact of automated vital signs captured using a PDA with bar-code technology for patient identification. The PDA enabled the wireless capture and transmission of data directly from the vital sign monitor into the EMR. Researchers reviewed 1514 sets of vital signs collected electronically for accuracy and compared the error rate with data from the previous paper and EMR systems. Automated upload of vital signs directly into an EMR reduced the documentation error rate to less than 1%. This represented a significant reduction in vital sign documentation errors with the use of mobile technology when compared with traditional charting methods (P < .001). ”
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea. Dependent claims recite additional subject matter which amount to limitations consistent additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 3-5 and 8 additional limitations which amount to elements that have been recognized as activities in particular fields, claims 3-5 and 8, e.g., performing repetitive calculations, Flook, MPEP §2106.05(d)(II)(ii); claims 3-5 and 8, e.g., storing and retrieving information in memory, Versata Dev. Group, MPEP §2106.05(d)(II)(iv). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, claims 1, 3-5, and 8 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Examiner Note Regarding Amendments
Applicant introduces several amendments that are not explicitly supported by Applicant specification. However, they represent features that would be understood to be the standard implementation of said features to one of ordinary skill in the art. Examiner lists the relevant features below by claim.
Claim 1:
“a code generation controller configured to modulate luminance of display pixels to generate a machine-readable optical code”
Although Applicant specification makes no mention of modulating luminance of display pixels, creating a digital code using a code generator would require the pixels on the screen to modulate to create/display the code, as evidenced by Sutheebanjard (Sutheebanjard; Phaisarn, QR-Code Generator, 2010, Eighth International Conference on ICT and Knowledge Engineering), pg 1: “If we copy http://goo.gl/H3xr into a new browser window and append “.qr” to the end of the link as: http://goo.gl/H3xr.qr, the QR code will be shown as in Fig. 2.” It would be obvious that this digital method of generating a QR code would modulate the pixels of the display output to display the QR code.
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“wherein the optical code comprises a patient identifier, measurement data, a measurement timestamp, and an error-correction checksum”
Although Applicant specification makes no mention of an error-correction checksum, this is an inherent feature of QR codes, as evidenced by:
CSFieldGuide, Coding - Error control 9.4. QR codes, 4 Mar 2022, CSFieldGuide: Pg. 2 recites: “When one bit is changed (either white to black, or black to white), it’s easy for the software to detect that this has happened, and it can change it back. However, QR codes use a stronger error control code than the parity trick; even if you change several bits, it can usually work out the original message. This is error correction at work.” Pg. 4 recites: “A Universal Product Code (UPC) standard was developed that included a check digit to make scanning reliable, and this time an error detection checksum was used based on multiplying every second digit by 3… Because QR codes can store so much more data, it is a lot easier to add error correction bits to them, so they are capable of Forward Error Correction. This in turn has made them useful in places where they might be subject to wear and tear - printed on paper, stuck on notice boards, windows, and places that are exposed to the elements.”
Fast Reports; How to create a QR code with a picture, 9 Jan 2019, Fast Reports, which recites, on pg. 1: “The technology of QR codes contains redundancy (duplication of information) and a checksum. Therefore, even with 30 percent code corruption, it can be read. And the checksum ensures that it is read correctly.”
“wherein the optical code is one of a one-dimensional barcode or a two- dimensional matrix code compliant with ISO/JEC 18004 (e. g., QR-type code);”
Although Applicant specification makes no mention of ISO/JEC standards, ISO/JEC 18004 specifically refers to standards that are used when QR codes are involved. Thus, any usage of QR codes would teach upon the specified standard, as evidenced by pg. 9 of ISO, ISO/IEC 18004 Information technology — Automatic identification and data capture techniques — QR Code 2005 bar code symbology specification, 1 Feb 2015, ISO, which recites: “This International Standard defines the requirements for the symbology known as QR Code. It specifies the QR Code symbology characteristics, data character encoding methods, symbol formats, dimensional characteristics, error correction rules, reference decoding algorithm, production quality requirements, and user-selectable application parameters.”
Claim 3:
“a code recognition unit configured to recognize and decode the optical code captured by the camera using an image-processing or pattern-analysis algorithm stored in the user terminal”
Although Applicant specification makes no mention of image processing or pattern analysis algorithms, they are required to extract data from QR codes, as evidenced by pgs. 71-78 of ISO, ISO/IEC 18004 Information technology — Automatic identification and data capture techniques — QR Code 2005 bar code symbology specification, 1 Feb 2015, ISO, which teaches: “This reference decode algorithm finds the symbol in an image and decodes it. The decode algorithm refers to dark and lights states in the image.” Pg. 72, “b) Locate the finder pattern.”
“wherein the user terminal performs local decoding without reliance on external cloud services and automatically verifies the checksum included in the optical code before transmission to ensure data integrity”
Although Applicant specification makes no mention of verifying the checksum, this is a step that is automatically performed when decoding QR codes, as evidenced by CSFieldGuide, Coding - Error control 9.4. QR codes, 4 Mar 2022, CSFieldGuide and Fast Reports; How to create a QR code with a picture, 9 Jan 2019, Fast Reports, as shown above.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-5, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over McKirdy (US 20130032634) in view of Cardarelli (US 20110179361) further in view of Howell (US 6215992).
Regarding claim 1, McKirdy teaches a patient measurement device ([0023], “the method 100 includes generating user data via a device (such as an exercise device, a glucometer, a pedometer, etc.) as shown in operational block 152.”) comprising:
a measurement sensor configured to measure vital signs of a patient ([0023], “the method 100 includes generating user data via a device (such as an exercise device, a glucometer, a pedometer, etc.) as shown in operational block 152.” [0027], “It should be appreciated that the collected data may include any type of data suitable to the desired result, such as individual and/or machine performance data, machine setting/operation data, programmed regime data and/or biological data (such as heart rate, pulse rate, body fat, weight, height, pulse ox, etc.).”);
a code generation controller configured to modulate luminance of display pixels to generate a machine-readable optical code ([0023], “the method 100 includes generating user data via a device (such as an exercise device, a glucometer, a pedometer, etc.) as shown in operational block 152. The user data is then sent to a barcode generator, as shown in operational block 154, where the barcode generator may be integrated into the device generating the data… The barcode data may then be displayed in graphical form via a display screen (or via a physical printout), as shown in operational block 158.”),
wherein the optical code comprises measurement data, a measurement timestamp, and an error-correction checksum ([0055], “the barcode data may include data entered by hand into the mobile device, machine type and characteristics, date/time stamp for the workout/data transaction”),
wherein the optical code is one of a one-dimensional barcode or a two- dimensional matrix code compliant with ISO/JEC 18004 (e. g., QR-type code) ([0125], “the system may enables medical devices to have similar data capture capabilities, where a device like a blood glucose meter can display a digital barcode (QR code) that has information related to the test results of the user.”); and
wherein the patient measurement device is entirely non-wireless and isolated from any external network connection ([0050], “The invention also contemplates being able to use a stand-alone device that is in signal communication with the exercise machine either through a hardwired or wireless connection (or both) where the stand-alone device (being referred to also as a information processing and generation module) can retrieve the exercise and machine performance information (such as through serial communication with the exercise machine).”). It would be obvious to one of ordinary skill in the art that a stand-alone device that may have the option of only being able to communicate through hardwired means would be entirely non-wireless and isolated from any external network connection, especially if a wire is not connected to the device.
a user terminal physically separate from the patient measurement device ([0039], “It is contemplated that a user could use their own mobile device to perform the above function as long as the mobile device has optical sensing capabilities (smartphone, tablet PC or other mobile device).”), comprising:
a camera configured to capture the optical code from the display ([0025], “The method 300 includes uploading the barcode data into a mobile device, as shown in operational block 302, where this may be accomplished by activating the scanning software on the mobile device and exposing the barcode to the camera such that the scanning software can view and receive the image of the barcode.”);
a code recognition module configured to decode the captured optical code into measurement data ([0025], “the mobile device processes and analyzes the barcode data), as shown in operational block 308. The processed barcode data is then stored and displayed, as shown in operational block 310. It should be appreciated that the barcode data may be processed based on instructions inside of the barcode data, based on instructions in the software application processing the barcode data, based on the application for which the barcode data was generated and/or a combination of all or some of these.” [0125], “the system may enables medical devices to have similar data capture capabilities, where a device like a blood glucose meter can display a digital barcode (QR code) that has information related to the test results of the user.”);
a communication interface configured to transmit the decoded measurement data to a server exclusively through a secure communication network ([0073], “This machine asset data may then be processed via a mobile device or it may be uploaded to a remote server for processing (such as for diagnostics) and/or as desired for documentation and record keeping.” [0032], “the method may be used to capture bio-metric data from a kiosk (such as a health kiosk in a pharmacy) that is used to monitor and display a person's physical characteristics, such as body weight, pulse, blood pressure, body fat %, etc. This advantageously allows for an individual to capture, store and send private health information to a third party securely. For example, typically health kiosks must comply with strict HIPPA regulations and are thus constrained as to how personal health information is displayed (i.e. viewing angles, log in permissions, networking security, etc).”); and
a chart application configured to automatically populate an electronic patient chart with the decoded measurement data based on the patient identifier ([0073], “This machine asset data may then be processed via a mobile device or it may be uploaded to a remote server for processing (such as for diagnostics) and/or as desired for documentation and record keeping.” [0075], “This would allow the patient to send their test data to multiple sources and destinations as they desire for parallel diagnostics (their DNA, personal doctor, personal data file, electronic medical record, health insurance provider, etc).” [0092], “This information might also be shared with an electronic medical record, doctor, insurance provider, nutritionist, or other expert.” [0078], “apply data to various mobile health related software” [0088], “Another advantage includes the ability to more easily share data across multiple software applications without having to develop complicated backend web services type solutions that are typically used for sharing data between systems.”). One of ordinary skill in the art would recognize that that health related software may include a chart application used for documentation and record keeping of user vital sign information.
And a server configured to receive, store, and associate the transmitted measurement data with a patient record ([0073], “This machine asset data may then be processed via a mobile device or it may be uploaded to a remote server for processing (such as for diagnostics) and/or as desired for documentation and record keeping.” [0075], “This would allow the patient to send their test data to multiple sources and destinations as they desire for parallel diagnostics (their DNA, personal doctor, personal data file, electronic medical record, health insurance provider, etc).”),
wherein the patient monitoring system enables secure offline transmission of vital signs from the non-wireless patient measurement device to the network via optical code capture, thereby improving data integrity, cybersecurity, and device approval compliance in medical environments where radio transmission is restricted ([0065], “In one situation, a person might use a glucometer for monitoring their blood sugar levels, where the glucometer may be able to generate and display a barcode that is generated in response to the user's blood glucose measurement. As discussed herein the generated barcode can be uploaded (i.e. scanned or email/text (image)) using any mobile device. This is beneficial because although there are companies that provide BlueTooth enabled glucometer products, there is still a large challenge in how these devices can communicate with mobile devices due to several reasons, such as mobile device 3rd party software development restrictions and limits of data sharing on those devices with 3rd party hardware devices. The present invention allows a person to easily transfer their data simply by scanning a barcode that is generated in response to their measurements to a mobile device or other processing device.” [0092], “This information might also be shared with an electronic medical record, doctor, insurance provider, nutritionist, or other expert.” ([0032], “the method may be used to capture bio-metric data from a kiosk (such as a health kiosk in a pharmacy) that is used to monitor and display a person's physical characteristics, such as body weight, pulse, blood pressure, body fat %, etc. This advantageously allows for an individual to capture, store and send private health information to a third party securely. For example, typically health kiosks must comply with strict HIPPA regulations and are thus constrained as to how personal health information is displayed (i.e. viewing angles, log in permissions, networking security, etc).”)). The claim language indicates that improving device approval compliance and data security is an intended result of performing the functional steps of the remaining claim, and thus is not patentably limiting (see MPEP 2111.04). As McKirdy teaches the functional steps of the claim, it is considered to amount to the benefit of “improving device approval compliance and data security.”
Although McKirdy teaches a display of the patient measurement device ([0022], “The data generation device 102 is also associated with a display (and/or printer) device 108 for displaying the barcode that is generated.”) and transmitting data over secure networks, McKirdy does not explicitly teach a display configured to present the measured vital signs; wherein the code generator is configured to encode a patient identifier; and wherein the secure network is a secure internal hospital network.
However, Cardarelli does teach wherein the obtained measurement data is transmitted over a secure internal hospital communication network ([0075], “the data used just at the server includes the subset of parameters used by the vital data subsystem 160, a data message and data message schedule for sending the most recent values from the server 166 to the client 164, and a EMR query message for obtaining at the server 166 the most recent values for the subset from the EMR system.” [0029], “Some embodiments of the invention are described below in the context of client server communications between general purpose processors on a network in a hospital for patients that stay in the hospital.”). It would be obvious to one of ordinary skill in the art that a hospital communication network for processors in the hospital would be secured, as indicated by the need for HIPPA regulations (McKirdy, [0032], “typically health kiosks must comply with strict HIPPA regulations and are thus constrained as to how personal health information is displayed (i.e. viewing angles, log in permissions, networking security, etc).””)
and a display (120) configured to display the measured vital information ([0024], “FIG. 4 is a block diagram that illustrates an example arrangement of EMR parameter values displayed automatically at a patient's bedside, according to an embodiment;”).
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McKirdy in view of Cardarelli are considered analogous to the claimed invention because they are in the field of processing vital sign data. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified McKirdy with Cardarelli for the advantage of providing “client server communications between general purpose processors on a network in a hospital for patients that stay in the hospital” (Cardarelli; [0029]).
McKirdy in view of Cardarelli does not teach wherein the code generator is configured to encode a patient identifier.
However, Howell does teach wherein the code generator is configured to encode a patient identifier (Col. 7, lines 12-15, “Examples of bar code data employed in the health care industry includes those relating to: a patient's ID number; chart of vital signs; medicine containers; EKG graphs; X-ray films; and vials of blood and other body fluids.”).
McKirdy in view of Cardarelli further in view of Howell are considered analogous to the claimed invention because they are in the field of processing vital sign data. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified McKirdy in view of Cardarelli with Howell for the advantage of providing “client server communications between general purpose processors on a network in a hospital for patients that stay in the hospital” (Cardarelli; [0029]).
Regarding claim 3, McKirdy in view of Cardarelli further in view of Howell teaches the patient monitoring system of claim 1, as described above. McKirdy further teaches wherein the code recognition module comprises:
a code recognition unit configured to recognize and decode the optical code captured by the camera using an image-processing or pattern-analysis algorithm stored in the user terminal ([0030], “It should be appreciated that the method of the invention may be implemented via any device (mobile or other) that has the ability to capture digital images (i.e. scan and/or take pictures)” [0025], “exposing the barcode to the camera such that the scanning software can view and receive the image of the barcode”); and
a communication unit configured to transmit the decoded measurement data to the server only through the secure network without any Internet connection ([0073], “This machine asset data may then be processed via a mobile device or it may be uploaded to a remote server for processing (such as for diagnostics) and/or as desired for documentation and record keeping.” [0023], “A user may then upload the barcode data by scanning the barcode with their mobile device, as shown in operational block 160, where the mobile device processes the barcode data” [0032], “the method may be used to capture bio-metric data from a kiosk (such as a health kiosk in a pharmacy) that is used to monitor and display a person's physical characteristics, such as body weight, pulse, blood pressure, body fat %, etc. This advantageously allows for an individual to capture, store and send private health information to a third party securely. For example, typically health kiosks must comply with strict HIPPA regulations and are thus constrained as to how personal health information is displayed (i.e. viewing angles, log in permissions, networking security, etc).” [0029], “the data may be sent (via hardwire, cellular or wireless network) to a backend system for processing and/or display.”). Examiner notes that transmitting data using hardwire or cellular networks do not include internet connection. Furthermore, the explicit exclusion of Internet is not supported by Applicant specification as pg. 14 recites: “transmit the measurement data securely by using a hospital internal network in which a firewall and a security system are installed… any type of a wireless network, such as a mobile radio communication network, a satellite communication network, Bluetooth, a wireless broadband Internet (Wibro), High Speed Downlink Packet Access (HSDPA), long-term evolution (LTE), or 3/4/5/6th generation mobile telecommunication (3/4/5/6G).”
wherein the user terminal performs local decoding without reliance on external cloud services and automatically verifies the checksum included in the optical code before transmission to ensure data integrity ([0025], “The method 300 includes uploading the barcode data into a mobile device, as shown in operational block 302, where this may be accomplished by activating the scanning software on the mobile device and exposing the barcode to the camera such that the scanning software can view and receive the image of the barcode… It should be appreciated that the barcode data may be processed based on instructions inside of the barcode data, based on instructions in the software application processing the barcode data, based on the application for which the barcode data was generated and/or a combination of all or some of these.”). Examiner notes that scanning software on the mobile device is a form of local decoding. The claim language indicates that ensuring data integrity is an intended result of performing the functional steps of the remaining claim, and thus is not patentably limiting (see MPEP 2111.04). As McKirdy teaches the functional steps of the claim, it is considered to amount to the benefit of “ensur[ing] data integrity.”
McKirdy does not teach wherein the communication network is a secure internal hospital communication network.
However, Cardarelli does teach wherein the communication network is a secure internal hospital communication network ([0029], “Some embodiments of the invention are described below in the context of client server communications between general purpose processors on a network in a hospital for patients that stay in the hospital.”). It would be obvious to one of ordinary skill in the art that a hospital communication network for processors in the hospital would be secured, as indicated by the need for HIPPA regulations (McKirdy, [0032], “typically health kiosks must comply with strict HIPPA regulations and are thus constrained as to how personal health information is displayed (i.e. viewing angles, log in permissions, networking security, etc).””).
Regarding claim 5, McKirdy in view of Cardarelli further in view of Howell teaches the patient monitoring system of claim 1, as described above. McKirdy further teaches the system further comprising:
a code printing device ([0030], “the image can be displayed so that a device that has the ability to scan can scan in the image or it can be sent via email or text to a device that can print the barcode) configured to:
receive, from the patient measurement device, a print command through a short-range wired or limited-range local interface that does not provide Internet or network access ([0030], “the image can be displayed so that a device that has the ability to scan can scan in the image or it can be sent via email or text to a device that can print the barcode and/or interpret the barcode” [0110], “It should be appreciated that although the use of wireless data transmission and barcode scanning has been described, other methods of data transmission can be used to achieve the same desired result (physical data connection between radio device and mobile device, USB (means mobile device is plugged into radio device), Zigbee, BlueTooth and all variations of BlueTooth, Wi-Fi, RFID, Infrared/Microwave, etc).”); and
print the machine-readable optical code generated by the code generation controller ([0030], “the image can be displayed so that a device that has the ability to scan can scan in the image or it can be sent via email or text to a device that can print the barcode),
wherein the printed optical code includes the patient identifier, measurement timestamp, and checksum, and can be physically attached to a patient chart or specimen label within the hospital facility for offline record keeping ([0023], “the method 100 includes generating user data via a device (such as an exercise device, a glucometer, a pedometer, etc.) as shown in operational block 152. The user data is then sent to a barcode generator,… The barcode data may then be displayed in graphical form via a display screen (or via a physical printout)” [0055], “the barcode data may include data entered by hand into the mobile device, machine type and characteristics, date/time stamp for the workout/data transaction” [0125], “the system may enables medical devices to have similar data capture capabilities, where a device like a blood glucose meter can display a digital barcode (QR code) that has information related to the test results of the user.”). Examiner notes that any physical printout would be capable of being physical attached to any surface.
McKirdy in view of Cardarelli does not teach wherein the code generator is configured to encode a patient identifier.
However, Howell does teach wherein the code generator is configured to encode a patient identifier (Col. 7, lines 12-15, “Examples of bar code data employed in the health care industry includes those relating to: a patient's ID number; chart of vital signs; medicine containers; EKG graphs; X-ray films; and vials of blood and other body fluids.”).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over McKirdy (US 20130032634) in view of Cardarelli (US 20110179361) further in view of Howell (US 6215992) and Stockton (US 20090089094).
Regarding claim 8, McKirdy in view of Cardarelli further in view of Howell teaches the patient monitoring system of claim 1, as described above. McKirdy further teaches wherein the server comprises:
a server computer configured to receive, store, and manage the measurement data transmitted from the user terminal exclusively within a secure internal network that is physically and logically isolated from the Internet ([0073], “This machine asset data may then be processed via a mobile device or it may be uploaded to a remote server for processing (such as for diagnostics) and/or as desired for documentation and record keeping.” [0075], “This would allow the patient to send their test data to multiple sources and destinations as they desire for parallel diagnostics (their DNA, personal doctor, personal data file, electronic medical record, health insurance provider, etc).” [0032], “This advantageously allows for an individual to capture, store and send private health information to a third party securely.”);
Although McKirdy teaches transmitting data over secure networks, McKirdy does not explicitly teach wherein the secure network is a secure internal hospital network; and a web server module configured to provide monitoring data to authorized user terminals through authenticated sessions and encrypted communication channels wherein the server further records each data upload event and access log for audit tracking to ensure data integrity and regulatory compliance in accordance with medical device approval protocols.
However, Cardarelli does teach wherein the obtained measurement data is transmitted over a secure internal hospital communication network ([0075], “the data used just at the server includes the subset of parameters used by the vital data subsystem 160, a data message and data message schedule for sending the most recent values from the server 166 to the client 164, and a EMR query message for obtaining at the server 166 the most recent values for the subset from the EMR system.” [0029], “Some embodiments of the invention are described below in the context of client server communications between general purpose processors on a network in a hospital for patients that stay in the hospital.”). It would be obvious to one of ordinary skill in the art that a hospital communication network for processors in the hospital would be secured, as indicated by the need for HIPPA regulations (McKirdy, [0032], “typically health kiosks must comply with strict HIPPA regulations and are thus constrained as to how personal health information is displayed (i.e. viewing angles, log in permissions, networking security, etc).””)
McKirdy in view of Cardarelli further in view of Howell do not teach a web server module configured to provide monitoring data to authorized user terminals through authenticated sessions and encrypted communication channels wherein the server further records each data upload event and access log for audit tracking to ensure data integrity and regulatory compliance in accordance with medical device approval protocols.
However, Stockton does teach a web server module configured to provide monitoring data to authorized user terminals through authenticated sessions and encrypted communication channels ([0073], “the medical information system 12 utilizes database and application servers to operate the medical information system 12 and to store and transmit data.” [0037], “The patient data access control application 20 serves as a gatekeeper to prevent unauthorized users from accessing the patient data within the patient database 14.” [0002], “The Health Insurance Portability and Accountability Act ("HIPAA") set forth standards for the electronic exchange, privacy and security of health information.”). One of ordinary skill in the art would recognize that HIPAA laws require data encryption for electronic protected health information.
wherein the server further records each data upload event and access log for audit tracking to ensure data integrity and regulatory compliance in accordance with medical device approval protocols ([0022], “an audit log is generated whenever a user accesses protected health information within the patient database 14. The audit log is a record of a user's access to a patient's protected health information. In particular, the audit log records information that can enable the system 10 to determine what protected health information was accessed, who accessed it, and the process by which they accessed the information.”).
McKirdy in view of Cardarelli further in view of Howell and Stockton are considered analogous to the claimed invention because they are in the field of processing patient data. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified McKirdy in view of Cardarelli further in view of Howell with Stockton for the advantage of “prevent[ing] unauthorized users from accessing the patient data within the patient database” (Stockton; [0021]).
Claim 4 has been searched and considered and does not result in a prior art rejection at this time.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
System For Managing Access to Medical Data (US 20160117448) teaches a system for managing access to medical data, comprising a first module which displays data request information for requesting access to the medical data from the data provider, and a second module which obtains the data request information from the first module and requests access to the medical data from a data provider based on the obtained data request information. The first module can provide the data request information by Patient Physician displaying the data request information, for example as a quick-response (QR) code. The data request information may comprise a uniform resource locator (URL) linking to the data provider. The data provider can store the medical data locally or can retrieve the medical data from a remote source, such as a personal health record (PHR) server. In response to a data access request, the data provider may request user authentication from the patient to whom the medical data corresponds, and only provide the medical data to the second module in response to successful authorization.
Method For Processing Patient-Based Data Sets (WO 2013124014) teaches a method for processing patient-based data sets, wherein key data entered by the physician at the client computer 24 are converted into a QR code with the aid of a 2D bar code hash algorithm, and the QR code thus generated is combined with the QR code in the display data from the cloud. Computing Architecture 2 compared. If the two QR codes do not match, a backup function is triggered, as a result of which the display data is discarded by the client computer 24 and as a result an error notification appears on the monitor of the client computer 24, which alerts the physician that the display data is assigned to an unknown patient.
Portable Terminal Device, Control Method And Control Program Therefor, And Medical Information Management System (WO 2014050680) teaches a mobile terminal device 13 that is, for example, a PDA, a smart phone, or a tablet terminal on which a program for browsing medical information is installed. Since this personal digital assistant device 13 is concealed from personal information when it is outside the communication garden of the in-hospital network 14, it is restricted to use within the medical institution and is prohibited from being taken out of the medical institution.
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.
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/D.C./Examiner, Art Unit 3684
/Shahid Merchant/Supervisory Patent Examiner, Art Unit 3684