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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/04/2026 has been entered.
Response to Arguments
Applicant’s arguments filed 02/04/2026 have been fully considered but are not persuasive or are moot in view of a new grounds of rejection.
Applicant argues, “the claim integrates such abstract idea into a practical application. In particular, amended claim 1 recites a combination of elements that, as a whole, provide an improvement over prior systems by optimizing memory storage, resulting in improved wound monitoring and/or treatment that integrates the aforementioned abstract idea into a practical application.”
Examiner respectfully disagrees. Specifically, claim 1 recites controlling data being stored based on authorization to collect patient data, and there is nothing in the claims which show how stopping patient data collection in response to an indication or storing at least one of location information, therapy time, or time that system has been powered on and preventing storing the patient data associated with the treatment results in the judicial exception being integrated into a practical application.
Applicant argues, “As another example, the update to MPEP § 2106.05(f) provides that "other cases have found that additional elements are more than 'apply it' or are not 'mere instructions' when the claims recites a technological solution to a technological problem," for example, "in ExParte Desjardins, the claims reflected a specific improvement that addressed the technical problem ... while allowing artificial intelligence systems to variously optimize system performance, use less storage capacity and reduce system complexity."
Examiner respectfully disagrees. Authorizing patient data based on a confirmation that the dressing is placed over a wound and in response to receiving the authorization to collect the patient data, storing the patient data is interpreted as an additional element. The claim is directed toward mere instructions to apply the exception in a generic manner using a computer, as well as extra solution-activity. There is nothing in the claims which shows the judicial exception being integrated into a practical application. Thus the claimed invention still does not overcome the 35 U.S.C. 101 rejection since claims 1 and 15 are still directed to abstract ideas and are therefore not patent eligible.
Applicant argues, “Similarly, amended claim 1 recites storing "patient data associated with the treatment in the memory" only "in response to receiving, via the transceiver, from the external computing device the authorization to collect the patient data" and until receiving "an indication by the HCP to stop patient data collection." Storage of patient data associated with treatment is prevented if the authorization is not received. As a result, the amount of data that is recorded in memory is optimized to prevent storing any unnecessary data. Accordingly, amended claim 1 improves the operation of wound monitoring and/or treatment systems by limiting the storage of patient data associated with treatment to a particular period of time when the authorization is received, which improves memory capacity and power consumption, leading to increased performance and improvements to system functionality.”
Examiner respectfully states that although the instant invention may lead to increased performance and improvements to system functionally, there is nothing in the claims which shows the judicial exception being integrated into a practical application. As stated above, the claimed invention still does not overcome the 35 U.S.C. 101 rejection since claims 1 and 15 are still directed to abstract ideas and are therefore not patent eligible.
Applicant argues, “Furthermore, amended claim 1 recites, among other limitations, causing "adjustment of one or more parameters associated with the treatment based on the collected patient data stored in the memory" after receiving the authorization to collect the patient data that is associated with treatment. Similarly, if authorization is not received, a reduced amount of data is recorded, as amended claim 1 recites "1) store in the memory data comprising at least one of location information, therapy time, or time that system has been powered on and 2) prevent storing the patient data associated with the treatment in the memory." This improves the functioning of monitoring and/or treatment systems by optimizing memory storage, reducing memory wear, improving the service life of memory, and saving power.”
Examiner respectfully disagrees. Adjustment of the parameters only occurs once the authorization to collect patient data is received. If no authorization is received, then patient data associated with the treatment is not stored and data associated with either location information, therapy time, or time the system was powered on is stored. The above recited limitations are directed to additional elements, specifically extra post-solution activity. There is nothing in the claims which shows how the claim as a whole integrates the judicial exception into a practical application.
Further, Examiner asserts that even if the claims optimize memory storage, reduce memory wear, improve the service life of memory, and save power, the claimed invention still does not overcome the 35 U.S.C. 101 rejection since claims 1 and 15 are still directed to abstract ideas and are therefore not patent eligible.
Applicant argues, “In addition, amended claim 1 is patent eligible for similar reasons as stated in Example 40 of the Subject Matter Eligibility Examples (available at https://www.uspto.gov/sites/default/files/documents/101_examples_37to42_20190107.pdf). In that example, claim 1 was deemed to be patent eligible because "the method limits collection of additional Netflow protocol data to when the initially collected data reflects an abnormal condition, which avoids excess traffic volume on the network and hindrance of network performance." Amended claim 1 similarly avoids collecting excess patient data, which improves the operation of wound monitoring and/or treatment systems.”
Examiner respectfully disagrees. In Example 40, the claim as a whole integrates the mental process into a practical application. Thus, the claim is eligible because it is not directed to the recited judicial exception. However, in this instance, claim 1 as a whole does not integrate the mental process into a practical application. Specifically, there is nothing in the claims which shows how preventing data from being stored when authorization is not received integrates the judicial exception into a practical application. Further, Examiner asserts that even if the claims optimize memory storage, reduce memory wear, improve the service life of memory, and save power, the claimed invention still does not overcome the 35 U.S.C. 101 rejection since claims 1 and 15 are still directed to abstract ideas and are therefore not patent eligible.
Applicant argues, “the cited references, alone or combined, do not disclose or suggest at least "determining that the patient data comprises valid physiological data not associated with the treatment" and, if so, "in response to receiving from the external computing device the authorization to collect the patient data: with the sensor, collect the patient data associated with the treatment", as recited in amended claim 1 (emphasis added). The Office Action relies on paragraph [0061] and [0070] of Shen to reject the aforementioned limitations, but fails to indicate how the cited portions disclose or suggest a differentiation between determining that sensor data is "valid physiological data not associated with the treatment" and subsequently collecting "patient data associated with the treatment," as recited in amended claim 1.”
Examiner respectfully disagrees. Regarding the limitation, “determining that the patient data comprises valid physiological data not associated with the treatment", Shen teaches determining if the patient data comprises valid physiological data that is not associated with a treatment ([0070]: determination may be made if detected a biometric parameter such as temperature, which is not associated with a treatment, falls within predefined values; [0026]).
Specifically, Shen uses physiological parameters ([0070]: “skin capacitance, respiratory rate, heart rate, and temperature”) to detect if the sensing system [0070] is properly attached [0070]. These physiological parameters are not associated with treatment because they’re used to detect whether errors are occurring in regards to the positioning of the sensing system [0070]. Further, when these physiological parameters detect improper positioning of orientation sensors [0070], then a caregiver is alerted to reposition and reattach the sensing system to the patient [0070].
Shen also teaches in response to receiving programming to collect the patient data with the sensor ([0061]: programming to receive data 200 from the sensor),
collect the patient data associated with the treatment ([0061]: data 200 is collected to verify proper function; [0056]), and
store the patient data associated with the treatment in the memory ([0056]: sensor data is stored; [0061]: sensor data includes pressure related data) and
cause adjustment of one or more parameters associated with the treatment based on the collected patient data stored in the memory ([0057]: output includes providing suggestions regarding patient care; [0061]: pressure used to provide determination such as repositioning the patient, which would adjust one or more parameters i.e. pressure associated with treating pressure ulcers; [0026]; fig. 2).
Specifically, Shen is directed toward treating pressure ulcers [0012] by optimizing surface pressure [0012]. Once Shen determines that the sensor is functioning properly and being used [0061], then it moves onto generating an orientation-based pressure map [0061], which is used in a determination about repositioning the patient [0061-0062]. Shen also teaches that orientation pressure data can be used to recommend optimal repositioning maneuvers [0069]. Shen further teaches that repositioning would provide treatment [0005] so that little or no pressure is placed on the ulcer [0005].
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, 7-13, 15, 17, 19, 21-23, 26, 28-29, and 31-32 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, specifically an abstract idea without significantly more.
Step 1:
Independent claims 1 and 15 recite a wound monitoring system and a method of authorizing collection of patient data. Thus, they are directed to statutory categories of invention.
Step 2A, Prong 1:
Claims 1 and 15 recite the following claim limitations which are directed to abstract ideas, specifically organizing human activity and mental processes (see MPEP § 2106.04(a)(2), subsections II and III):
Claim 1:
“determine based on the patient data measured by the sensor if the dressing, housing, or dressing and housing is placed in or over the wound, skin, or wound and skin of the patient” (observation and judgement or evaluation, which is grouped as a mental process under the 2019 PEG – doctor can visually determine if the dressing is placed in or over the wound of a patient)
“the determination being performed based on determining if the patient data comprises valid physiological data that is not associated with a treatment” (mental process – doctor can determine if the dressing is properly placed on the patient)
“in response to determining that the dressing, housing, or dressing and housing is placed in or over the wound, skin, or wound and skin of the patient data not associated with the treatment” (mental process – see above),
“communicate….a confirmation that the dressing, housing, or dressing and housing is placed in or over the wound, skin, or wound and skin of the patient” (observation and judgement or evaluation, which is grouped as a mental process under the 2019 PEG – doctor can use pen and paper to write down a confirmation that the dressing is placed in or over the wound of the patient, or they can also verbally say it to the patient) and
receive an authorization from a healthcare provider (HCP) to collect the patient data (organizing human activity because a healthcare provider must provide authorization before patient data is collected; collecting patient data can be an assessment of the patient)
Claim 15: see claim 1 above
These limitations, under their broadest reasonable interpretation, cover concepts that can be practically performed in the human mind, i.e., using pen and paper. For instance, determining if the dressing is placed over the wound doesn’t have to be done using a controller and could be performed in the human mind just from observing a patient wearing a wound monitoring device. Furthermore, the limitations “communicate….a confirmation that the dressing…is placed in or over the wound…” can be broken down into moving information around, which is capable of being performed in the human mind. Furthermore, the limitation “the determination being performed based on determining if the patient data comprises valid physiological data” can be done by a doctor confirming that the dressing is indeed positioned correctly on the wound/skin of the patient.
Therefore, the claim limitations fall within the 'mental processes' and ‘organizing human activity’ grouping of abstract ideas.
Step 2A, Prong 2:
Claims 1 and 15 recite the following additional elements:
Claim 1:
“a dressing, housing, or dressing and housing configured to be placed in or over a wound, skin, or wound and skin of a patient;
a sensor positioned on or in the dressing, housing, or dressing and housing and configured to measure patient data,
the sensor comprising at least one of a
pressure sensor,
conductivity sensor,
blood oxygen saturation sensor,
optical sensor,
pH sensor,
temperature sensor, or
motion sensor;
a transceiver; and
a controller configured to
receive the patient data measured by the sensor,
selectively store the patient data in a memory, and
communicate, via the transceiver, at least some of the patient data stored in the memory to an external computing device,
….communicate, via the transceiver, to the external computing device a confirmation that the dressing, housing, or dressing and housing is placed in or over the wound, skin, or wound and skin of the patient and cause the external computing device to receive an authorization from a healthcare provider (HCP) to collect the patient data;
in response to receiving, via the transceiver, from the external computing device the authorization to collect the patient data with the sensor, collect the patient data associated with the treatment, and store the patient data associated with the treatment in the memory and cause adjustment of one or more parameters associated with the treatment based on the collected patient data stored in the memory;
receive, via the transceiver, from the external computing device an indication by the HCP to stop patient data collection and in response to receiving the indication, prevent storing in memory at least some of the patient data measured by the sensor subsequent to receipt of the indication; and
in response to not receiving, via the transceiver, from the external computing device the authorization to collect the patient data,
store in the memory data comprising at least one of
location information,
therapy time, or
time that system has been powered on and
2) prevent storing the patient data associated with the treatment in the memory”.
Claim 15: see limitations in claim 1 above
The following limitations:
“a dressing, housing, or dressing and housing configured to be placed in or over a wound, skin, or wound and skin of a patient;
a sensor positioned on or in the dressing, housing, or dressing and housing and configured to measure patient data,
the sensor comprising at least one of a
pressure sensor,
conductivity sensor,
blood oxygen saturation sensor,
optical sensor,
pH sensor,
temperature sensor, or
motion sensor”,
are pre-solution activities (see MPEP 2106.05(g)), because they’re used to obtain additional information about the patient’s wound in order to confirm that the dressing is on the wound of the patient.
Additionally, the following claim limitations directed to the transceiver and controller:
“a transceiver; and
a controller configured to
receive the patient data measured by the sensor,
selectively store the patient data in a memory, and
communicate, via the transceiver, at least some of the patient data stored in the memory to an external computing device,
….communicate, via the transceiver, to the external computing device a confirmation that the dressing, housing, or dressing and housing is placed in or over the wound, skin, or wound and skin of the patient and cause the external computing device to receive an authorization from a healthcare provider (HCP) to collect the patient data;
in response to not receiving, via the transceiver, from the external computing device the authorization to collect the patient data,
store in the memory data comprising at least one of
location information,
therapy time, or
time that system has been powered on and
2) prevent storing the patient data associated with the treatment in the memory”
are directed towards the transceiver and external computer being used to communicate a confirmation to an external computer that the dressing is placed over a wound as well as authorizing patient data collection and recording. This step is not extra-solution activity, but rather is the, albeit broad, solution related to the computer-implemented process of the claim. However, authorizing patient data based on a confirmation that the dressing is placed over a wound and in response to receiving the authorization to collect the patient data, storing the patient data is neither particular enough to meaningfully limit the recited exception nor does it have more than a nominal relationship to the exception.
In other words, the breadth of the recited “store” is such that it substantially encompasses all applications of the recited exception (such as recording and organizing data), while storing being “in response to receiving” the “authorization to collect the patient data” represents a merely nominally relationship with the exception. In fact, the claimed step effectively constitutes mere instructions to apply the exception in a generic manner using a computer.
Regarding the limitations,
“in response to receiving, via the transceiver, from the external computing device the authorization to collect the patient data with the sensor, collect the patient data associated with the treatment, and store the patient data associated with the treatment in the memory and cause adjustment of one or more parameters associated with the treatment based on the collected patient data stored in the memory” and
“receive, via the transceiver, from the external computing device an indication by the HCP to stop patient data collection and in response to receiving the indication, prevent storing in memory at least some of the patient data measured by the sensor subsequent to receipt of the indication”,
Examiner asserts that these limitations are directed to additional elements, specifically insignificant post solution activity (see MPEP 2106.05(g)).
The above recited limitations merely process information and then output the results of the above identified abstract ideas. Additionally, the recited “cause adjustment” is neither particular enough to meaningfully limit the recited exception nor does it have more than a nominal relationship to the exception. In other words, the breadth of the recited “cause adjustment” is such that it substantially encompasses all applications of the recited exception (such as moving information around rather than requiring the adjusted parameters associated with the treatment to be applied to the patient in a way that provides a particular prophylaxis or a practical application).
In other words, there is nothing in the claims which show how storing the patient data and causing adjustment of one or more parameters associated with the treatment integrates the judicial exception into a practical application or provides a particular prophylaxis.
Further, there is no evidence of record that would support the assertion that this step is an improvement to a computer or a technological solution to a technological problem. Rather, Applicant’s specifications [0086, 0098] ultimately describe that the improvement of the claim relates to storing data based on a confirmed authorization to collect the patient data rather than practically using the stored data. (See MPEP 2106.04(d)(2), 2106.05(a), and 2106.05(f)).
Additionally, claim 1 and 15’s recitation of a transceiver, external computing device, and controller are merely reciting the computer components at a high-level of generality. In other words, the computer components are being used as a tool to carry out the system’s functions (See MPEP 2106.05(f)).
Thus, the abstract idea is not integrated into a practical application. The combination of these additional elements is no more than insignificant extra solution activity, and mere instructions to apply the exception using generic computer components (transceiver, controller, memory, and external computing device). Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application. The claim is directed to an abstract idea.
Step 2B:
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than insignificant extra solution activity and mere instructions to apply the exception using a generic computer component.
Additionally, Applicant’s specifications do not provide structure or detailed drawings of the transceiver, controller, memory, or external computing device” (see [0040], [0078-0079], [0078], [0097] respectively). The same analysis applies here in 2B and does not provide an inventive concept.
Therefore, none of the claims 1, 3-5, 7-13, 15, 17, 19, 21-23, 26, 28-29, and 31-32 amount to significantly more than the abstract idea itself. Accordingly, claims 1, 3-5, 7-13, 15, 17, 19, 21-23, 26, 28-29, and 31-32 are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al. and 2019 PEG.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, 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.
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, 10-11, 13, 15, 21, 23,28, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Shen et al. (US 2015/0254956) in view of Hansen (US 2013/0276144) in view of Chu (US 2015/0006395).
In re claim 1, Shen discloses a wound [0056] monitoring [0056] and/or treatment system (fig. 1D: 110; [0057]) comprising:
a dressing, housing (fig. 1B: exterior of sensors 110), or dressing and housing configured to be placed in or over a wound [0056], skin [0106], or wound and skin of a patient [0056, 0106];
a sensor (110)
positioned on or in the dressing, housing [0060], or dressing and housing and
configured to measure patient data [0056],
the sensor comprising at least one of
a pressure sensor [0061],
conductivity sensor,
blood oxygen saturation sensor,
optical sensor [0063],
pH sensor [0063],
temperature sensor [0070], or
motion sensor [0067];
a transceiver (fig. 1B: combination of wireless communications); and
a controller (120) configured to
receive the patient data measured by the sensor (125; [0079, 0061]),
selectively store the patient data in a memory (135; [0061]: data is processed if the sensor is functioning properly), and
communicate, via the transceiver, at least some of the patient data stored in the memory to an external computing device ([0057-0058]: wirelessly communicates with external computing device i.e. 130/140),
the controller further configured to: determine based on the patient data measured by the sensor if the dressing, housing, or dressing and housing is placed in or over the wound, skin, or wound and skin of the patient ([0070]: detects if sensor system is properly attached to the patient by using biometric parameters, for instance temperature),
the determination being performed based on determining if the patient data comprises valid physiological data that is not associated with a treatment ([0070]: determination may be made if detected a biometric parameter such as temperature, which is not associated with a treatment, falls within predefined values; [0012]: treatment is directed toward pressure ulcers by optimizing surface pressure; [0061]: physiological data associated with a treatment is any data related to pressure; [0026]);
in response to determining that the dressing, housing, or dressing and housing is placed in or over the wound, skin, or wound and skin of the patient based on determining that the patient data comprises valid physiological data not associated with the treatment [0070]: communicate, via the transceiver, to the external computing device a confirmation that the dressing, housing, or dressing and housing is placed in or over the wound, skin, or wound and skin of the patient ([0070]: if sensing system is properly secured, host system communicates to 140 or 130 based on stored data; [0061]: data is only analyzed if the system is functioning properly, therefore if the external computing device receives sensor data, then the system is properly placed; [0070]);
in response to receiving programming to collect the patient data with the sensor ([0061]: programming to receive data 200 from the sensor),
collect the patient data associated with the treatment ([0061]: data 200 is collected to verify proper function; [0056]), and
store the patient data associated with the treatment in the memory ([0056]: sensor data is stored; [0061]: sensor data includes pressure related data) and
cause adjustment of one or more parameters associated with the treatment based on the collected patient data stored in the memory
([0057]: output includes providing suggestions regarding patient care; [0061-0062]: pressure used to provide determination such as repositioning the patient, which would adjust one or more parameters i.e. pressure associated with treating pressure ulcers; [0005]: treatment includes positioning patients such that little or no pressure is placed on the ulcer; [0026]; fig. 2).
Shen fails to disclose
in response to determining that the dressing, housing, or dressing and housing is placed in or over the wound, skin, or wound and skin of the patient based on determining that the patient data comprises valid physiological data not associated with the treatment…cause the external computing device to receive an authorization from a healthcare provider (HCP) to collect the patient data;
in response to receiving, via the transceiver, from the external computing device the authorization to collect the patient data with the sensor…
receive, via the transceiver, from the external computing device an indication by the HCP to stop patient data collection and in response to receiving the indication, prevent storing in memory at least some of the patient data measured by the sensor subsequent to receipt of the indication; and
in response to not receiving, via the transceiver, from the external computing device the authorization to collect the patient data:
1) store in the memory data comprising at least one of location information, therapy time, or time that system has been powered on and
2) prevent storing the patient data associated with the treatment in the memory.
Hansen teaches an analogous wireless monitoring sensor system [0073] wherein the controller ([0023]; Fig. 1B: 110, 105: gateway 110 is the controller since it communicates with the sensors 105) is configured to:
determine based on patient data measured by the sensor if the glucose monitoring sensor is placed in or over the skin of the patient ([0073]: the patient has to be using the device for the measurement to be taken, which alerts the sensor to send the data to a glucose monitoring application; [0057]),
the determination being performed based on determining if the patient data comprises valid physiological data ([0057]: patient data from sensor must be validated either by checking data with a sensor database 178, or by validating an uploader’s credentials);
in response to determining that the glucose sensor is placed over the skin of the patient, communicate, via the transceiver, to the external computing device a confirmation that the dressing, housing, or dressing and housing is placed in or over the wound, skin, or wound and skin of the patient ([0073]: once a glucose measurement has been taken, the sensor sends the data to a glucose monitoring application (i.e. confirmation that the device was placed on the skin) which then sends the data to the server) and cause the external computing device (Fig. 1C: 170) to receive an authorization from a healthcare provider (HCP) ([0024]: the gateway communicates with the enumeration server to authenticate data management; [0073-0074]: the doctor registered to the glucose monitoring application is a healthcare provider) to collect the patient data [0073];
wherein the controller is configured to receive, via the transceiver, from the external computing device an indication by the HCP to stop patient data collection (Fig. 4A: 410; Fig. 4B: 411, 412, 414; [0057-0058]: the patient data collection starts with the system initially asking the user if they want to upload data (410) and receives the data uploader’s credentials as well as the data when they select “Yes” (411), but then stops the patient data collection if the data uploader is not authenticated (414)); and in response to receiving the indication [0058], prevent storing in memory at least some of the patient data measured by the sensor subsequent to receipt of the indication ([0059]: the data is only stored when the data and uploader is authenticated; [0056-0057]: the data being uploaded can be data measured by the sensor that will be compared with the sensor data repository).
in response to receiving, via the transceiver [0022], from the external computing device the authorization to collect the patient data with the glucose sensor ([0073]: gateway and wireless glucose sensor are authenticated and occur at a first time),
collect the patient data associated with monitoring ([0073]: authorization permits data that has been collected for blood glucose monitoring to be stored), and
store the patient data associated with the monitoring in the memory [0073]; and
in response to not receiving, via the transceiver, from the external computing device the authorization to collect the patient data (Fig. 4B: “No” response to decision 413 and occurs at a second time), prevent storing the patient data in the memory (414; [0058]).
Hansen further teaches that authenticating the sensors and validating the data in the system allows the data analysis obtained from the system to be reliable and traceable [0011]. Furthermore, Hansen teaches the glucose monitoring system assures the physician that the data was collected on a registered glucose sensor, and that they can rely on the data collected because the server authenticated the sensor and the gateway before storing the data, which makes it more secure and traceable [0074].
Additionally, Hansen teaches that consumer confidence is established when identity of the analysts is established and only authorized users are able to access the data [0014]. Hansen further teaches that the human collecting data from the sensors and uploading it should be authorized to collect the data from the sensors so that only data from registered sensors are uploaded to the database [0026]. Hansen additionally teaches that preventing patient data from being stored in response to not receiving authorization validates the credibility of the data and allows the device to further keep a log of the access requests, which provides traceability of the data [0057].
Moreover, Hansen teaches that stopping the patient data collection if the data uploader is not authenticated validates the credibility of the data and allows the device to further keep a log of the access requests, which provides traceability of the data [0057].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the wound monitoring device taught by Shen, to provide wherein the controller of the wound monitoring system of Shen is further configured to determine based on the patient data measured by the sensor if the dressing, housing, or dressing and housing is placed in or over the wound, skin, or wound and skin of the patient, in response to determining that the dressing, housing, or dressing and housing is placed in or over the wound, skin, or wound and skin of the patient based on determining that the patient data comprises valid physiological data, communicate, via the transceiver, to the external computing device a confirmation that the dressing is placed on the skin of the patient and cause the external computing device to receive an authorization from a healthcare provider (HCP) to collect the patient data; in response to receiving, via the transceiver, from the external computing device the authorization to collect the patient data: with the sensor, collect the patient data associated, and store the patient data measured by the sensor in the memory, receive, via the transceiver, from the external computing device an indication by the HCP to stop patient data collection and in response to receiving the indication, prevent storing in memory at least some of the patient data measured by the sensor subsequent to receipt of the indication; and in response to not receiving, via the transceiver, from the external computing device the authorization to collect the patient data, prevent storing the patient data in the memory, as taught by Hansen, because doing so would allow for the data collected by the monitoring device to be traceable, secure, and reliable, as well as establish consumer confidence by confirming that only authorized users collect data from the registered sensors before uploading the data to the database, and also provides a log of when data was requested to be uploaded, which provides traceability and credibility of the data.
Regarding the limitation “in response to not receiving, via the transceiver, from the external computing device the authorization to collect the patient data, store in the memory data comprising at least one of
location information,
therapy time, or
time that system has been powered on,”
Chu teaches receiving authentication before supplying wireless power to an electronic device [0010], and teaches in response to not receiving authorization [0054], storing a location of a wireless charging device [0054] in a memory ([0054]: Authentication failure message sent to controller 300 which can use the authentication failure message to diagnose failure issues).
Chu further teaches that the authentication failure message can be used to diagnose the reason that authorization was not successful and provide assistance if needed [0054].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the wound monitoring device yielded by the proposed combination, to provide storing in the memory data comprising location information in response to not receiving the authorization, as taught by Chu, because the authentication failure message can be used to diagnose the reason that authorization was not successful and provide assistance if needed.
Regarding the limitations,
“in response to determining that the dressing, housing, or dressing and housing is placed in or over the wound, skin, or wound and skin of the patient based on determining that the patient data comprises valid physiological data not associated with the treatment…cause the external computing device to receive an authorization from a healthcare provider (HCP) to collect the patient data;
in response to receiving, via the transceiver, from the external computing device the authorization to collect the patient data with the sensor,
collect the patient data associated with the treatment, and
store the patient data associated with the treatment in the memory and
cause adjustment of one or more parameters associated with the treatment based on the patient data stored in the memory; and
in response to not receiving, via the transceiver, from the external computing device the authorization to collect the patient data:
1) store in the memory data comprising at least one of location information, therapy time, or time that system has been powered on and
2) prevent storing the patient data associated with the treatment in the memory”,
the proposed combination above yields the above recited limitations. Specifically, Shen teaches using temperature to determine if the housing is placed over the skin of the patient based on the temperature being within a threshold (see above), and then proposed combination yields this determination causing the external computing device to receive an authorization from a healthcare provider (HCP) to collect the patient data, as taught by Hansen, which results in the temperature data of Shen being collected and stored, as well as the pressure data of Shen, which is associated with treating pressure ulcers, to be used to adjust the patient’s position, so that pressure ulcers are either treated or prevented. The proposed combination further yields that, in response to not receiving the authorization to collect the patient data, location information is stored, as taught by Chen, and patient data which includes pressure information would also not be stored in the memory, as taught by Hansen, because only data that is traceable, secure, and reliable should be stored (see above).
In re claim 3, the proposed combination yields (all mapping directed to Shen unless otherwise stated) wherein
the sensor comprises the temperature sensor (see in re claim 1 above) and
the controller is configured to determine that the dressing, housing, or dressing and housing is placed in or over the wound, skin, or wound and skin of the patient in response to determining that patient temperature measured by the temperature sensor is within a physiological temperature range ([0070]: temperature must be within predefined values based on known physiological behavior to determine proper attachment).
In re claim 10, the proposed combination yields (all mapping directed to Shen unless otherwise stated) wherein the sensor comprises the pH sensor [0063] and the controller is configured to determine that the dressing, housing, or dressing and housing is placed in or over the wound, skin, or wound and skin of the patient in response to determining that pH level measured by the pH sensor is within a physiological pH threshold ([0203]: threshold number of readings used to indicate that the sensor is attached; [0070]: biometric parameters must be within predefined limits; [0063]: pH is part of sensors of the system).
In re claim 11, the proposed combination yields (all mapping directed to Shen unless otherwise stated) wherein the sensor comprises the motion sensor [0067] and the controller is configured to determine that the dressing, housing, or dressing and housing is placed in or over the wound, skin, or wound and skin of the patient in response to determining that motion data measured by the motion sensor satisfies a motion threshold indicative of an activity of the patient ([0113]: acceleration thresholds can be used to detect if physical contact with the patient is lost).
In re claim 13, the proposed combination fails to yield
wherein the authorization includes a first time stamp indicating a start of a patient data collection episode,
wherein the indication includes a second time stamp indicating an end of the patient data collection episode, and
wherein the controller is further configured to associate patient data stored after receiving the first time stamp and before receiving the second time stamp as being associated with the patient data collection episode.
Hansen teaches:
wherein the authorization includes a first time stamp indicating a start of a patient data collection episode ([0057]: access requests is the first time stamp),
wherein the indication includes a second time stamp indicating an end of the patient data collection episode ([0059]: the time the uploading occurs is the second time stamp), and
wherein the controller is further configured to associate patient data stored after receiving the first time stamp and before receiving the second time stamp as being associated with the patient data collection episode ([0057-0059]: the time between the request and the time the data is uploaded is considered a data collection episode).
Hansen further teaches that that keeping a log of the access requests further validates the credibility of the data, the sensor data repository, and even the data analysts so that confirmation is received that the data being uploaded is authorized [0057].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the wound monitoring device yielded by the proposed combination, to provide wherein the authorization includes a first time stamp indicating a start of a patient data collection episode, wherein the indication includes a second time stamp indicating an end of the patient data collection episode, and wherein the associates patient data stored after receiving the first time stamp and before receiving the second time stamp as being associated with the patient data collection episode, as taught by Hansen, because doing so provides traceability and credibility of the data since a record of when the request to upload data will be recorded as well as additional information about the sensors and the one uploading the data.
In re claim 15, regarding the limitations “a method of collecting patient data with a wound monitoring and/or treatment system, the method comprising:
by a controller configured to be in communication with a dressing, housing, or dressing and housing configured to be placed in or over a wound, skin, or wound and skin of a patient,
wherein a sensor is positioned on or in the dressing, housing, or dressing and housing, and wherein the sensor is configured to measure patient data:
determining based on the patient data measured by the sensor if the dressing, housing, or dressing and housing is placed in or over the wound, skin, or wound and skin of the patient,
the determining being performed based on determining if the patient data comprises valid physiological data that is not associated with treatment; and
in response to determining that the dressing, housing, or dressing and housing is placed in or over the wound, skin, or wound and skin of the patient based on determining that the patient data comprises valid physiological data not associated with the treatment:
communicating to an external computing device a confirmation that the dressing, housing, or dressing and housing is placed in or over the wound, skin, or wound and skin of the patient and
causing the external computing device to receive an authorization from a healthcare provider (HCP) to collect the patient data;
at a first time, in response to receiving from the external computing device the authorization to collect the patient data with the sensor,
collecting the patient data associated with the treatment, and
storing the patient data associated with the treatment measured by the sensor in a memory and
causing adjustment of one or more parameters associated with the treatment based on the collected patient data stored in the memory;
receiving from the external computing device an indication by the HCP to stop patient data collection; and in response to receiving the indication, preventing storing in memory at least some of the patient data measured by the sensor subsequent to receipt of the indication; and
at a second time, in response to not receiving from the external computing device the authorization to collect the patient data,
storing in the memory data comprising at least one of
location information,
therapy time, or
time that the system has been powered on and
2) preventing storing the patient data associated with the treatment in the memory”,
see the proposed combination yielded in re claim 1 above.
In re claim 21, the proposed combination yields wherein:
the sensor comprises a conductivity sensor and the method comprises:
determining that conductivity measured by the conductivity sensor satisfies a conductivity threshold indicative of conductivity of a living tissue; and
determining that the dressing, housing, or dressing and housing is placed in or over the wound, skin, or wound and skin of the patient in response to determining that conductivity measured by the conductivity sensor satisfies the conductivity threshold; or
the sensor comprises an optical sensor and the method comprises:
determining that image data measured by the optical sensor is associated with image data of a wound, skin, or wound and skin; and
determining that the dressing, housing, or dressing and housing is placed in or over the wound, skin, or wound and skin of the patient in response to determining that image data measured by the optical sensor is associated with image data of the wound, skin, or wound and skin; or
the sensor comprises a blood oxygen saturation sensor and the method comprises:
determining that blood oxygen saturation measured by the blood oxygen saturation sensor is within a physiological blood oxygen saturation range; and
determining that the dressing, housing, or dressing and housing is placed in or over the wound, skin, or wound and skin of the patient in response to determining that blood oxygen saturation measured by the blood oxygen saturation sensor is within the physiological blood oxygen saturation range; or
the sensor comprises a pH sensor (see in re claim 10 above) and the method comprises:
determining that pH level measured by the pH sensor is within a physiological pH threshold range (see in re claim 10 above); and
determining that the dressing, housing, or dressing and housing is placed in or over the wound, skin, or wound and skin of the patient in response to determining that pH level measured by the pH sensor is within the physiological pH threshold range (see in re claim 10 above); or
the sensor comprises a motion sensor (see in re claim 11 above) and the method comprises:
determining that motion data measured by the motion sensor satisfies a motion threshold indicative of an activity of the patient (see in re claim 11 above); and
determining that the dressing, housing, or dressing and housing is placed in or over the wound, skin, or wound and skin of the patient in response to determining that motion data measured by the motion sensor satisfies the motion threshold (see in re claim 11 above).
In re claim 23, regarding the limitation “wherein the authorization includes a first time stamp indicating a start of a patient data collection episode, wherein the indication includes a second time stamp indicating an end of the patient data collection episode, and wherein the method comprises associating patient data stored after receiving the first time stamp and before receiving the second time stamp as being associated with the patient data collection episode”, see above (in re claim 13).
In re claim 28, regarding the limitation “wherein the sensor comprises a temperature sensor and determining that the dressing, housing, or dressing and housing is placed in or over the wound, skin, or wound and skin of the patient is performed based on determining that patient temperature measured by the temperature sensor is within a physiological temperature range”, see in re claim 3 above.
In re claim 32, the proposed combination yields (all mapping directed to Shen unless otherwise stated) wherein in response to determining that the dressing, housing, or dressing and housing is not placed in or over the wound, skin, or wound and skin of the patient based on determining that the patient data is not valid physiological data ([0070]: biometric parameter not being within predefined limits means improper attachment), provide an indication to the patient to adjust the dressing, housing, or dressing or housing to be placed in or over the wound, skin, or wound and skin of the patient ([0070]: improper attachment to the patient provides an alert to the patient, which would indicate that adjustment is needed).
Claims 4 & 17 are rejected under 35 U.S.C. 103 as being unpatentable over Shen et al. (US 2015/0254956) in view of Hansen (US 2013/0276144) in view of Chu (US 2015/0006395) in view of Bloom et al. (US 6963772) in view of Choi et al. (US 2016/0058366).
In re claim 4, the proposed combination fails to yield comprising an ambient temperature sensor positioned on or in the dressing, housing, or dressing and housing and configured to measure an ambient temperature, wherein the controller is configured to determine that the dressing, housing, or dressing and housing is placed in or over the wound, skin, or wound and skin of the patient in response to determining that a difference between temperature measured by the sensor and the ambient temperature satisfies a temperature difference threshold.
Bloom teaches an analogous wound monitoring device (Col. 2, lines 54-63) comprising an ambient temperature sensor (Fig. 3: 24: one sensor patch 24 is located adjacent to the wound; Col. 11, lines 31-37) positioned on the dressing (36) and another temperature sensor (24: one sensor patch is located at the wound site; Col. 8, lines 53-57) wherein the wound monitoring device is configured to measure an ambient temperature difference between temperature measured by the sensor and the ambient temperature (Col. 8, lines 25-28).
Bloom further teaches that knowing the stored temperature data can be used to detect if a wound is healing normally or if there is an infection depending on how the wound temperature compares to the baseline temperature (i.e., ambient temperature) over time (Col. 6. Lines 54 – Col. 7, lines 1-2).
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the wound monitoring device yielded by the proposed combination to provide wherein the system comprises an ambient temperature sensor positioned on the dressing and configured to measure an ambient temperature, as taught by Bloom, because doing so will allow for the wound to be monitored for possible infections and signs of normal healing when the ambient temperature difference is considered.
Choi teaches wherein the controller (Fig. 2: 120) is configured to determine that the user is wearing the wearing the monitoring device based on thresholds measured by the temperature sensor [0080].
Choi teaches wherein the controller (Fig. 2: 120) is configured to determine that the user is wearing the wearing the monitoring device based on thresholds measured by the temperature sensor [0080].
Choi further teaches that signals from the biometric sensor are used to determine if the monitoring device is being worn by the patient [0076], and that the biometric sensor may include other sensors (photo sensor, GSR sensor, temperature sensor) that can be used to determine if the monitoring device is being worn [0081]. Choi further teaches that determining when the device is worn and when it is taken off using the thresholds allows for the data to be more accurately compared in case continuous monitoring occurs while the device is not actually being worn [0157], such as if a patient takes the device off after activating it. Furthermore, Choi also teaches that determining when the device is worn and taken off helps to reduce power consumption [0013].
One of ordinary skill in the art at the time the instant invention was filed would readily appreciate that similarly to how Choi detects if a patient is wearing the device by determining if the temperature is past a certain threshold, any other parameter capable of changing when the device is worn could also be used to determine if the device is worn. For instance, the parameter of a difference between temperature measured by a sensor and ambient temperature could be used since the difference would change based on the device being worn by the patient.
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the wound monitoring device yielded by the proposed combination, to provide wherein the controller is configured to determine that the dressing is placed on the skin of the patient in response to determining that a difference between temperature measured by the sensor and the ambient temperature satisfies a temperature difference threshold, as similarly taught by the temperature sensor in Choi, because doing so will provide a more accurate representation of when the device is worn, reduce power consumption, and because the parameter of pressure (similar to the parameter of temperature) will also change when the device is worn.
In re claim 17 regarding the limitation,
“wherein an ambient temperature sensor is positioned on or in the dressing, housing, or dressing and housing and is configured to measure an ambient temperature,
wherein the sensor comprises a temperature sensor, and
wherein the method comprises:
determining that a difference between temperature measured by the sensor and the ambient temperature satisfies a temperature difference threshold; and
in response to determining that the difference between temperature measured by the sensor and the ambient temperature satisfies the temperature difference threshold, determining that the dressing, housing, or dressing and housing is placed in or over the wound, skin, or wound and skin of the patient”,
see claim 4 above.
Claims 5, 29, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Shen et al. (US 2015/0254956) in view of Hansen (US 2013/0276144) in view of Chu (US 2015/0006395) in view of Weston (WO 2009/089390).
In re claim 5, the proposed combination yields (all mapping directed to Shen unless otherwise stated) wherein the sensor comprises the pressure sensor ([0063]: pressure sensors) and the controller is configured to determine that the dressing, housing, or dressing and housing is placed in or over the wound, skin, or wound and skin of the patient (see in re claim 1 above).
The proposed combination fails to yield wherein…. the controller is configured to:
operate a negative pressure source to provide negative pressure wound therapy to the wound of the patient and
determine that the dressing, housing, or dressing and housing is placed in or over the wound, skin, or wound and skin of the patient in response to determining that pressure measured by the pressure sensor over a time duration matches a pressure profile indicative of a steady state condition during application of negative pressure wound therapy.
Weston teaches treating a wound (fig. 3: 22) by applying negative pressure to the wound [0002, 0033], and teaches wherein a controller (32) is configured to
operate a negative pressure source (26) to provide negative pressure wound therapy to the wound of a patient [0033] and
determine that a dressing (24) is placed in or over the wound of the patient (fig. 3) in response to determining that pressure measured by a pressure sensor (fig. 4A: 137; [0049]) over a time duration matches a pressure profile indicative of a steady state condition (fig. 2: steady state is a constant level of pressure as shown from 2C to 2D; [0061]) during application of negative pressure wound therapy ([0057-0061]: pressure sensor measures changes in pressure within the dressing over time which indicates that the dressing is placed over the wound and constant level of pressure is achieved within the wound dressing; fig. 2).
Weston further teaches that cycling between applying negative pressure in a constant manner and then releasing the negative pressure assists patients with chronic wounds by healing the wounds in a rapid and efficient manner [0008].
It would be obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the wound monitoring device yielded by the proposed combination, to provide wherein the controller is configured to: operate a negative pressure source to provide negative pressure wound therapy to the wound of the patient and determine that the dressing, housing, or dressing and housing is placed in or over the wound, skin, or wound and skin of the patient in response to determining that pressure measured by the pressure sensor over a time duration matches a pressure profile indicative of a steady state condition during application of negative pressure wound therapy, as taught by Weston, because doing so assists patients with chronic wounds by healing the wounds in a rapid and efficient manner.
In re claim 29, regarding the limitations “wherein the sensor comprises a pressure sensor and the method further comprises:
with a negative pressure source, providing negative pressure wound therapy to the wound of the patient;
determining that that pressure measured by the pressure sensor over a time duration matches a pressure profile indicative of a steady state condition during application of negative pressure wound therapy; and
in response to determining that that pressure measured by the pressure sensor over the time duration matches the pressure profile indicative of the steady state condition during application of negative pressure wound therapy, determining that the dressing, housing, or dressing and housing is placed in or over the wound, skin, or wound and skin of the patient,”
see in re claim 5 above.
In re claim 31, the proposed combination fails to yield wherein the controller is configured to cause adjustment of one or more parameters associated with the treatment by causing adjustment of an operation of a negative pressure wound therapy device that applies negative pressure wound therapy to the patient.
Weston teaches wherein the controller is configured to cause adjustment of one or more parameters associated with the treatment ([0102]: adjust negative pressure) by causing adjustment of an operation of a negative pressure wound therapy device ([0102]: adjust negative pressure; [0102-0103]: data collected from sensors 84 using recording device 90 is used to adjust therapy parameters) that applies negative pressure wound therapy to the patient [0102].
Weston further teaches that the stored patient data can be monitored depending on whether various measurements exceed or fall below different thresholds [0102], so that an alarm can be sounded [0084], and so negative pressure may be adjusted based on the stored patient data [0084, 0102], which allows for faster healing of the wound ([0083-0084]: if blood oxygen saturation level falls below an optimal value, negative pressure is increased, which increases blood flow, which allows for faster healing of the wound).
Weston additionally teaches that providing negative pressure heals wounds in a rapid and efficient manner [0008].
The proposed combination would incorporate the negative pressure therapy of Weston, and use the stored patient data to adjust the therapy parameters.
It would be obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the wound monitoring device yielded by the proposed combination, to provide wherein the controller is configured to adjust one or more therapy parameters based on the patient data stored in the memory, as taught by Weston, because negative pressure is used to heal wounds in a rapid and efficient manner, and monitoring stored patient data provides alarms when the stored patient data falls outside of an optimal level, and allows therapy to be adjusted based on the stored patient data, which allows for faster healing of the wound.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Shen et al. (US 2015/0254956) in view of Hansen (US 2013/0276144) in view of Chu (US 2015/0006395) in view of Choi et al. (US 2016/0058366) [in view of Bly et al. (US 2015/0031964)].
In re claim 7, the proposed combination yields (all mapping directed to Shen unless otherwise stated) wherein the sensor comprises the conductivity sensor ([0063]: inductive sensor is a conductivity sensor) and the controller is configured to determine that the dressing, housing, or dressing and housing is placed in or over the wound, skin, or wound and skin of the patient (see in re claim 1 above).
The proposed combination fails to yield wherein the controller is configured to determine that the dressing, housing, or dressing and housing is placed in or over the wound, skin, or wound and skin of the patient in response to determining that conductivity measured by the conductivity sensor satisfies a conductivity threshold indicative of conductivity of a living tissue.
Choi teaches wherein the controller (Fig. 2: 120) is configured to determine that the user is wearing the wearing the monitoring device based on thresholds indicative of conductivity of a living tissue ([0079]: measured electrical conductivity between two points on skin is used to determine if the electronic device is worn and will inherently measure a conductivity indicative of a living tissue i.e. the measured conductivity of the human body as measured by a GSR sensor).
Choi further teaches that determining when the device is worn and when it is taken off using the thresholds allows for the data to be more accurately compared in case continuous monitoring occurs while the device is not actually being worn [0157], such as if a patient takes the device off after activating it. Furthermore, Choi also teaches that determining when the device is worn and taken off helps to reduce power consumption [0013].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the wound monitoring device yielded by the proposed combination, to provide the controller is configured to determine that the dressing is placed on the skin of the patient in response to determining that conductivity measured by the conductivity sensor satisfies a conductivity threshold indicative of conductivity of a living tissue, because doing so will provide a more accurate representation of when the device is worn, reduce power consumption, and because the parameter of conductivity (similar to temperature) will also change when the device is worn.
Although the proposed combination yields determining that the user is wearing the monitoring device based on thresholds indicative of conductivity of a living tissue as discussed above, in case the proposed combination fails to yield wherein the thresholds are indicative of conductivity of a living tissue, it would be obvious to modify the proposed combination to yield wherein determining that the user is wearing the monitoring device is based on thresholds indicative of conductivity of a living tissue.
Bly teaches a physiological signal detecting device (fig. 18: 302) comprising of a variety of sensors [0137] and teaches determining that the physiological signal detecting device is being worn and/or worn properly based on each sensor being within a particular range [0137].
One of ordinary skill in the art at the time the instant invention was filed would readily appreciate that similarly to how Bly detects if a patient is wearing the device by determining if each sensor is within a particular range for a living tissue i.e. the part of the sensor in contact with the patient, any other parameter capable of changing when the device is worn could also be used to determine if the device is worn. For instance, the parameter of conductivity of a living tissue would change based on the device being worn by the patient.
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the thresholds of the wound monitoring device yielded by the proposed combination, to be indicative of conductivity of a living tissue, as taught by the sensors in Bly each having a particular range for determining if the physiological signal detecting device is worn, for substantially the same reasons as discussed in re claim 3 above.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Shen et al. (US 2015/0254956) in view of Hansen (US 2013/0276144) in view of Chu (US 2015/0006395) in view of Cernasov et al. (US 2017/0202711) in view of Choi et al. (US 20160058366).
In re claim 8, the proposed combination fails to yield wherein the sensor comprises the optical sensor and the controller is configured to determine that the dressing, housing, or dressing and housing is placed in or over the wound, skin, or wound and skin of the patient in response to determining that image data measured by the optical sensor is associated with image data of a wound, skin, or wound and skin.
Cernasov teaches an analogous bandage for treating a wound ([0023]) wherein the sensor comprises an optical sensor (Fig. 13a: 1310) and wherein the optical sensor stores image data of a wound [0044].
Cernasov further teaches that the optical sensor allows for visual monitoring of the wound [0044], which is beneficial because it can be done without opening the plate that encompasses the wound and exposing the wound to the atmosphere [0056].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the wound monitoring device yielded by the proposed combination, to provide wherein the sensor comprises the optical sensor and the image data measured by the optical sensor is associated with image data of a wound, as taught by Cernasov, because doing so will provide visual monitoring of the wound without having to expose the wound to the atmosphere.
Choi teaches wherein the controller (Fig. 2: 120) is configured to determine that the user is wearing the wearing the monitoring device based on thresholds measured by the temperature sensor [0080].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the wound monitoring device yielded by the proposed combination, to provide the controller is configured to determine that the dressing is placed on the skin of the patient in response to determining that image data measured by the optical sensor is associated with image data of a wound, as explained in claim 4 above by the temperature sensor in Choi being substituted by another parameter that changes when it is worn, because doing so will provide a more accurate representation of when the device is worn, reduce power consumption, and because the parameter of image data (similar to temperature) will also change when the device is worn.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Shen et al. (US 2015/0254956) in view of Hansen (US 2013/0276144) in view of Chu (US 2015/0006395) in view of Cernasov et al. (US 2017/0202711) in view of Choi et al. (US 20160058366) in view of Bly et al. (US 2015/0031964).
In re claim 9, the proposed combination fails to yield wherein the sensor comprises the blood oxygen saturation sensor and the controller is configured to determine that the dressing, housing, or dressing and housing is placed in or over the wound, skin, or wound and skin of the patient in response to determining that blood oxygen saturation measured by the blood oxygen saturation sensor is within physiological blood oxygen saturation range.
Cernasov teaches wherein the sensor (Fig. 13C: 1316) comprises a blood oxygen saturation sensor ([0045]: both the spectrometer and the near infrared imager can be used to measure blood oxygen saturation). Cernasov further teaches that the optical sensor provides a way to visually monitor the wound [0044] and can be done without having to expose the wound to the atmosphere [0056].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the wound monitoring device yielded by the proposed combination, to provide wherein the device incorporates a sensor comprising of the blood oxygen saturation sensor, as taught by Cernasov, because doing so will allow the wound to be monitored visually without having to expose it to the atmosphere.
Regarding the limitation “in response to determining that blood oxygen saturation measured by the blood oxygen saturation sensor is within physiological blood oxygen saturation range”, Bly teaches a physiological signal detecting device (fig. 18: 302) comprising of a variety of sensors [0137] and teaches determining that the physiological signal detecting device is being worn and/or worn properly based on each sensor being within a particular range [0137].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the wound monitoring device yielded by the proposed combination, to provide the controller is configured to determine that the dressing is placed on the skin of the patient in response to determining that blood oxygen saturation measured by the blood oxygen saturation sensor is within physiological blood oxygen saturation range, as explained in claim 7 above by the sensor in Bly being substituted by another parameter that changes when it is worn based on a particular range, for substantially the same reasons discussed in re claim 7 above.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Shen et al. (US 2015/0254956) in view of Hansen (US 2013/0276144) in view of Chu (US 2015/0006395) in view of Jaecklein (WO 2015/023515) in view of Choi et al. (US 2016/0058366).
In re claim 19, the proposed combination fails to yield
wherein an ambient pressure sensor is positioned on or in the dressing, housing, or dressing and housing and is configured to measure an ambient pressure,
wherein the sensor comprises a pressure sensor, and
wherein the method comprises:
determining that a difference between pressure measured by the pressure sensor and the ambient pressure satisfies a pressure difference threshold; and
in response to determining that the difference between pressure measured by the pressure sensor and the ambient pressure satisfies the pressure difference threshold, determining that the dressing, housing, or dressing and housing is placed in or over the wound, skin, or wound and skin of the patient.
Jaecklein teaches an analogous wound therapy apparatus [0004]
wherein an ambient pressure sensor (fig. 2E: any of one sensors 280, 282; [0052])
is positioned in a housing (230) and
is configured to measure an ambient pressure [0052],
wherein a sensor (284) comprises a pressure sensor (284), and
wherein the method comprises: determining that a difference between pressure measured by the pressure sensor and the ambient pressure [0053] satisfies a pressure difference threshold [0053].
Jaecklein further teaches that the monitored pressure signals are compared to a threshold to determine if the dressing is full or is at a particular level of exudate [0081], and that an additional pressure sensor can be used to monitor for high pressure conditions and for backup in case one of the pressure sensors become defective [0053].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the wound monitoring device yielded by the proposed combination to provide wherein the system incorporates an ambient pressure sensor positioned on the housing, and determines whether a difference between a pressure measured by the pressure sensor and the ambient pressure satisfies a pressure difference threshold, as taught by Jaecklein, because doing so will allow for the wound to be monitored for levels of exudate and high pressure, as well as provide a backup pressure sensor in case one of pressure sensors fail.
Choi teaches wherein the controller (Fig. 2: 120) is configured to determine that the user is wearing the wearing the monitoring device based on thresholds measured by the temperature sensor [0080].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the wound monitoring device yielded by the proposed combination, to provide wherein the controller is configured to determine that the dressing is placed on the skin of the patient in response to determining that the difference between pressure measured by the pressure sensor and the ambient pressure satisfies the pressure difference threshold, as explained in claim 4 above by the temperature sensor in Choi being substituted by another parameter that changes when it is worn, because doing so will provide a more accurate representation of when the device is worn, reduce power consumption, and because the parameter (i.e. a difference between pressure measured by the pressure sensor and the ambient pressure), similar to the parameter of temperature, will also change when the device is worn.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Shen et al. (US 2015/0254956) in view of Hansen (US 2013/0276144) in view of Chu (US 2015/0006395) in view of Goetz (US 2010/0223020).
In re claim 26, the proposed combination fails to yield wherein the controller is further configured to determine that of the patient data comprises valid physiological data not associated with the treatment based on
the patient performing a movement requested by the HCP and
the patient data measured by the sensor during the movement satisfying one or more thresholds indicating that the sensor is working.
Goetz teaches an analogous system which monitors a patient via one more sensors [0002, 0102], wherein
patient data is measured by the sensor ([0102]: sensor information 36 outputted by the sensor 51 during calibration),
a controller [0069] is further configured to determine that the patient data comprises valid physiological data ([0102]: valid physiological data is sensor information 36 being used for calibration of sensor 51 so that new calibration settings are generated) not associated with the treatment ([0102]: sensor data used for calibration, not treatment) based on
a patient performing a movement requested by a HCP ([0102]: clinician instructs patient to assume a desired movement which is outputted by sensor 51) and
the patient data measured by the sensor during the movement satisfying one or more thresholds indicating that the sensor is working ([0102]: sensor 51 having an output where sensor information 36 is received is considered as satisfying one or more thresholds indicating that the sensor is working i.e. the minimum output needed for the senor to pick up information is met).
Goetz further teaches that any problems with calibration settings of the sensor can affect the sensor’s ability to correctly identify a particular patient movement [0031], which can result in ineffective or inappropriate therapy [0031-0032].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the wound monitoring device yielded by the proposed combination, to provide wherein the controller is further configured to determine that the patient data comprises valid physiological data not associated with the treatment based on the patient performing a movement requested by the HCP and the patient data measured by the sensor during the movement satisfying one or more thresholds indicating that the sensor is working, as taught by Goetz, because any problems with calibration settings of the sensor can affect the sensor’s ability to correctly identify a particular patient movement, which can result in ineffective or inappropriate therapy.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Wedekind et al. (US 2017/0281060) discloses an analyte monitoring system (abstract) and teaches preventing storing in memory [0239] at least some of patient data [0238-0239] measured by a sensor subsequent to receipt of the indication ([0238-0239]: once stop command is received, storage of measurements in the memory unit is stopped).
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUMAISA R BAIG whose telephone number is (571)270-0175. The examiner can normally be reached Mon-Fri: 8am- 5pm.
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, David Hamaoui can be reached on (571) 270-5625. 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.
/RUMAISA RASHID BAIG/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796